Polaris 4.75 Deformity System
5.5 HA Multi Screw 7.5 X 50MM Dual-Lead
11manufacturers in China registered for this device type
721catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Highridge Medical, LLC, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2025-11-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-587113T | Device Size Text, specify—4.75X130MM TI ALLOY HEX ROD | In distribution |
| 14-584836 | Device Size Text, specify—4.75 TI 8.5X120MM FIXED SCREW | In distribution |
| 14-562231 | Device Size Text, specify—POL4.75 OPEN MAS 5.0X115MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-588545T | Device Size Text, specify—4.75/5.5X450MM TI ALLOY ROD | In distribution |
| 14-586420CL | Device Size Text, specify—4.5/4.75X200MM COCR LOW ROD | In distribution |
| 14-581835 | Device Size Text, specify—4.75 TI 3.5MM EXTENDED HOOK | In distribution |
| 14-563935 | Device Size Text, specify—POL4.75 CLOSED MAS 9.5X35MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-562699 | Device Size Text, specify—POL4.75 OPEN MAS 7.0X100MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-562199 | Device Size Text, specify—POL4.75 OPEN MAS 4.5X100MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-587130CS | Device Size Text, specify—4.75X300MM COCR STD HEX ROD | In distribution |
| 14-584665 | Device Size Text, specify—4.75 TI 7.0X65MM FIXED SCREW | In distribution |
| 14-584720 | Device Size Text, specify—4.75 TI 7.5X20MM FIXED SCREW | In distribution |
| 14-562060 | Device Size Text, specify—POL4.75 OPEN MAS 4.0X60MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-588551CH | In distribution | |
| 14-584441 | Device Size Text, specify—4.75 TI 6.0X125MM FIXED SCREW | In distribution |
| 14-562370 | Device Size Text, specify—POL4.75 OPEN MAS 5.5X70MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-586430T | Device Size Text, specify—4.5/4.75X300MM TI ALLOY ROD | In distribution |
| 14-588520CH | Device Size Text, specify—4.75/5.5X200MM COCR HIGH ROD | In distribution |
| 14-584666 | Device Size Text, specify—4.75 TI 7.0X150MM FIXED SCREW | In distribution |
| 14-563968 | Device Size Text, specify—POL4.75 CLOSED MAS 10.5X150MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-563960 | Device Size Text, specify—POL4.75 CLOSED MAS 9.5X60MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-584799 | Device Size Text, specify—4.75 TI 7.5X100MM FIXED SCREW | In distribution |
| 14-585230CL | Device Size Text, specify—4.5X300MM COCR LOW MR CRV ROD | In distribution |
| 14-584620 | Device Size Text, specify—4.75 TI 7.0X20MM FIXED SCREW | In distribution |
| 14-584922 | Device Size Text, specify—4.75 TI 9.5X22.5MM FIXED SCREW | In distribution |
| 14-581650L | Device Size Text, specify—4.75 TI 5MM LEFT OFFSET HOOK | In distribution |
| 14-562441 | Device Size Text, specify—POL4.75 OPEN MAS 6.0X125MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-562440 | Device Size Text, specify—POLARIS 4.75 6.0MM X 40MM Multiaxial Screw | In distribution |
| 14-587330T | Device Size Text, specify—4.75X300MM TI ALLOY LS CRV ROD | In distribution |
| 14-562360 | Device Size Text, specify—POL4.75 OPEN MAS 5.5X60MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-562121 | Device Size Text, specify—POL4.75 OPEN MAS 4.5X105MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-584937 | Device Size Text, specify—4.75 TI 9.5X120MM FIXED SCREW | In distribution |
| 14-563725 | Device Size Text, specify—POL4.75 CLOSED MAS 7.5X25MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-584727 | Device Size Text, specify—4.75 TI 7.5X27.5MM FIXED SCREW | In distribution |
| 14-563722 | Device Size Text, specify—POL4.75 CLOSED MAS 7.5X22.5MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-562120 | In distribution | |
| 14-584450 | Device Size Text, specify—4.75 TI 6.0X50MM FIXED SCREW | In distribution |
| 14-562230 | In distribution | |
| 14-584740 | Device Size Text, specify—4.75 TI 7.5X40MM FIXED SCREW | In distribution |
| 14-581640R | Device Size Text, specify—4.75 TI 4MM RT OFFSET HOOK | In distribution |
| 14-563665 | Device Size Text, specify—POL4.75 CLOSED MAS 7.0X65MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-562240 | In distribution | |
| 14-584495 | Device Size Text, specify—4.75 TI 6.0X95MM FIXED SCREW | In distribution |
| 14-563660 | Device Size Text, specify—POL4.75 CLOSED MAS 7.0X60MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-586430CL | Device Size Text, specify—4.5/4.75X300MM COCR LOW ROD | In distribution |
| 14-562260 | Device Size Text, specify—POL4.75 OPEN MAS 5.0X60MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-562140 | In distribution | |
| 14-562445 | Device Size Text, specify—POLARIS 4.75 6.0MM X 45MM Multiaxial Screw | In distribution |
| 14-562750 | Device Size Text, specify—POL4.75 OPEN MAS 7.5X50MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-587103CH | Device Size Text, specify—4.75X30MM COCR HIGH HEX ROD | In distribution |
| 14-562270 | Device Size Text, specify—POL4.75 OPEN MAS 5.0X70MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-562846 | Device Size Text, specify—POL4.75 OPEN MAS 8.5X130MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-562895 | Device Size Text, specify—POL4.75 OPEN MAS 8.5X95MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-584927 | Device Size Text, specify—4.75 TI 9.5X27.5MM FIXED SCREW | In distribution |
| 14-562427 | Device Size Text, specify—POLARIS 4.75 6.0MM X 27.5MM Multiaxial Screw | In distribution |
| 14-562426 | Device Size Text, specify—POL4.75 OPEN MAS 6.0X110MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-562721 | Device Size Text, specify—POL4.75 OPEN MAS 7.5X105MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-562646 | Device Size Text, specify—POL4.75 OPEN MAS 7.0X130MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-562720 | Device Size Text, specify—POL4.75 OPEN MAS 7.5X20MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-562322 | Device Size Text, specify—POLARIS 4.75 5.5MM X 22.5MM Multiaxial Screw | In distribution |
| 14-589111 | In distribution | |
| 14-563976 | Device Size Text, specify—POL4.75 CLOSED MAS 10.5X75MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-584627 | Device Size Text, specify—4.75 TI 7.0X27.5MM FIXED SCREW | In distribution |
| 14-584985 | Device Size Text, specify—4.75 TI 9.5X85MM FIXED SCREW | In distribution |
| 14-562866 | Device Size Text, specify—POL4.75 OPEN MAS 8.5X150MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-585151CL | Device Size Text, specify—4.5X510MM COCR LOW HEX ROD | In distribution |
| 14-562040 | In distribution | |
| 14-562640 | Device Size Text, specify—POL4.75 OPEN MAS 7.0X40MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-584966 | Device Size Text, specify—4.75 TI 10.5X65MM FIXED SCREW | In distribution |
| 14-585330T | Device Size Text, specify—4.5X300MM TI ALLOY LS CRV ROD | In distribution |
| 14-584631 | Device Size Text, specify—4.75 TI 7.0X115MM FIXED SCREW | In distribution |
| 14-563975 | Device Size Text, specify—POL4.75 CLOSED MAS 9.5X75MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-562431 | Device Size Text, specify—POL4.75 OPEN MAS 6.0X115MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-585213CL | Device Size Text, specify—4.5X130MM COCR LOW MR CRV ROD | In distribution |
| 14-562346 | Device Size Text, specify—POL4.75 OPEN MAS 5.5X130MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-585351CS | Device Size Text, specify—4.5X510MM COCR STD LS CRV ROD | In distribution |
| 14-562327 | Device Size Text, specify—POLARIS 4.75 5.5MM X 27.5MM Multiaxial Screw | In distribution |
| 14-584541 | Device Size Text, specify—4.75 TI 6.5X125MM FIXED SCREW | In distribution |
| 14-584846 | Device Size Text, specify—4.75 TI 8.5X130MM FIXED SCREW | In distribution |
| 14-562022 | In distribution | |
| 14-562051 | Device Size Text, specify—POL4.75 OPEN MAS 4.0X135MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-587313T | Device Size Text, specify—4.75X130MM TI ALLOY LS CRV ROD | In distribution |
| 14-588560CL | Device Size Text, specify—4.75/5.5X600MM COCR LOW ROD | In distribution |
| 14-563626 | Device Size Text, specify—POL4.75 CLOSED MAS 7.0X110MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-584947 | Device Size Text, specify—4.75 TI 9.5X130MM FIXED SCREW | In distribution |
| 14-562765 | Device Size Text, specify—POL4.75 OPEN MAS 7.5X65MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-584425 | Device Size Text, specify—4.75 TI 6.0X25MM FIXED SCREW | In distribution |
| 14-562056 | Device Size Text, specify—POL4.75 OPEN MAS 4.0X140MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-588520CL | Device Size Text, specify—4.75/5.5X200MM COCR LOW ROD | In distribution |
| 14-584865 | Device Size Text, specify—4.75 TI 8.5X65MM FIXED SCREW | In distribution |
| 14-584455 | Device Size Text, specify—4.75 TI 6.0X55MM FIXED SCREW | In distribution |
| 14-585113CS | Device Size Text, specify—4.5X130MM COCR STD HEX ROD | In distribution |
| 14-586451CH | Device Size Text, specify—4.5/4.75X510MM COCR HIGH ROD | In distribution |
| 14-562870 | Device Size Text, specify—POL4.75 OPEN MAS 8.5X70MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-584945 | Device Size Text, specify—4.75 TI 9.5X45MM FIXED SCREW | In distribution |
| 14-562066 | Device Size Text, specify—POL4.75 OPEN MAS 4.0X150MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-562685 | Device Size Text, specify—POL4.75 OPEN MAS 7.0X85MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-562222 | In distribution | |
| 14-584530 | Device Size Text, specify—4.75 TI 6.5X30MM FIXED SCREW | In distribution |
| 14-584520 | Device Size Text, specify—4.75 TI 6.5X20MM FIXED SCREW | In distribution |
| 14-586560T | Device Size Text, specify—4.5/5.5X600MM TI ALLOY ROD | In distribution |
| 14-563727 | Device Size Text, specify—POL4.75 CLOSED MAS 7.5X27.5MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-584550 | Device Size Text, specify—4.75 TI 6.5X50MM FIXED SCREW | In distribution |
| 14-585113CL | Device Size Text, specify—4.5X130MM COCR LOW HEX ROD | In distribution |
| 14-563939 | Device Size Text, specify—POL4.75 CLOSED MAS 10.5X110MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-584880 | Device Size Text, specify—4.75 TI 8.5X80MM FIXED SCREW | In distribution |
| 14-585213CS | Device Size Text, specify—4.5X130MM COCR STD MR CRV ROD | In distribution |
| 14-563954 | Device Size Text, specify—POL4.75 CLOSED MAS 10.5X135MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-586520CS | Device Size Text, specify—4.5/5.5X200MM COCR STD ROD | In distribution |
| 14-586445T | Device Size Text, specify—4.5/4.75X450MM TI ALLOY ROD | In distribution |
| 14-589106 | In distribution | |
| 14-562585 | Device Size Text, specify—POL4.75 OPEN MAS 6.5X85MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-586530CS | Device Size Text, specify—4.5/5.5X300MM COCR STD ROD | In distribution |
| 14-584566 | Device Size Text, specify—4.75 TI 6.5X150MM FIXED SCREW | In distribution |
| 14-586451CS | Device Size Text, specify—4.5/4.75X510MM COCR STD ROD | In distribution |
| 14-584990 | Device Size Text, specify—4.75 TI 9.5X90MM FIXED SCREW | In distribution |
| 14-584860 | Device Size Text, specify—4.75 TI 8.5X60MM FIXED SCREW | In distribution |
| 14-562627 | Device Size Text, specify—POL4.75 OPEN MAS 7.0X27.5MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-563699 | Device Size Text, specify—POL4.75 CLOSED MAS 7.0X100MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-584560 | Device Size Text, specify—4.75 TI 6.5X60MM FIXED SCREW | In distribution |
| 14-562236 | Device Size Text, specify—POL4.75 OPEN MAS 5.0X120MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-584535 | Device Size Text, specify—4.75 TI 6.5X35MM FIXED SCREW | In distribution |
| 14-584436 | Device Size Text, specify—4.75 TI 6.0X120MM FIXED SCREW | In distribution |
| 14-585160CL | Device Size Text, specify—4.5X600MM COCR LOW HEX ROD | In distribution |
| 14-585260CS | Device Size Text, specify—4.5X600MM COCR STD MR CRV ROD | In distribution |
| 14-587351CS | Device Size Text, specify—4.75X510MM COCR STD LS CRV ROD | In distribution |
| 14-562885 | Device Size Text, specify—POL4.75 OPEN MAS 8.5X85MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-562722 | Device Size Text, specify—POL4.75 OPEN MAS 7.5X22.5MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-584525 | Device Size Text, specify—4.75 TI 6.5X25MM FIXED SCREW | In distribution |
| 14-586551CH | Device Size Text, specify—4.5/5.5X510MM COCR HIGH ROD | In distribution |
| 14-584930 | Device Size Text, specify—4.75 TI 9.5X30MM FIXED SCREW | In distribution |
| 14-584421 | Device Size Text, specify—4.75 TI 6.0X105MM FIXED SCREW | In distribution |
| 14-562430 | Device Size Text, specify—POLARIS 4.75 6.0MM X 30MM Multiaxial Screw | In distribution |
| 14-587345CL | Device Size Text, specify—4.75X450MM COCR LOW LS CRV ROD | In distribution |
| 14-587113CH | Device Size Text, specify—4.75X130MM COCR HIGH HEX ROD | In distribution |
| 14-562631 | Device Size Text, specify—POL4.75 OPEN MAS 7.0X115MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-581630L | In distribution | |
| 14-585145CL | Device Size Text, specify—4.5X450MM COCR LOW HEX ROD | In distribution |
| 14-562330 | In distribution | |
| 14-587213CL | Device Size Text, specify—4.75X130MM COCR LOW MR CRV ROD | In distribution |
| 14-562655 | Device Size Text, specify—POL4.75 OPEN MAS 7.0X55MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-584721 | Device Size Text, specify—4.75 TI 7.5X105MM FIXED SCREW | In distribution |
| 14-588530T | Device Size Text, specify—4.75/5.5X300MM TI ALLOY ROD | In distribution |
| 14-562036 | Device Size Text, specify—POL4.75 OPEN MAS 4.0X120MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-562085 | Device Size Text, specify—POL4.75 OPEN MAS 4.0X85MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-587151CH | In distribution | |
| 14-562080 | Device Size Text, specify—POL4.75 OPEN MAS 4.0X80MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-562399 | Device Size Text, specify—POL4.75 OPEN MAS 5.5X100MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-563670 | Device Size Text, specify—POL4.75 CLOSED MAS 7.0X70MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-563666 | Device Size Text, specify—POL4.75 CLOSED MAS 7.0X150MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-584975 | Device Size Text, specify—4.75 TI 9.5X75MM FIXED SCREW | In distribution |
| 14-584921 | Device Size Text, specify—4.75 TI 10.5X20MM FIXED SCREW | In distribution |
| 14-562860 | Device Size Text, specify—POL4.75 OPEN MAS 8.5X60MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-562450 | Device Size Text, specify—POLARIS 4.75 6.0MM X 50MM Multiaxial Screw | In distribution |
| 14-584435 | Device Size Text, specify—4.75 TI 6.0X35MM FIXED SCREW | In distribution |
| 14-587230CS | Device Size Text, specify—4.75X300MM COCR STD MR CRV ROD | In distribution |
| 14-562250 | In distribution | |
| 14-562845 | Device Size Text, specify—POL4.75 OPEN MAS 8.5X45MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-585360T | Device Size Text, specify—4.5X600MM TI ALLOY LS CRV ROD | In distribution |
| 14-584590 | Device Size Text, specify—4.75 TI 6.5X90MM FIXED SCREW | In distribution |
| 14-562255 | Device Size Text, specify—POL4.75 OPEN MAS 5.0X55MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-585245CS | Device Size Text, specify—4.5X450MM COCR STD MR CRV ROD | In distribution |
| 14-584970 | Device Size Text, specify—4.75 TI 9.5X70MM FIXED SCREW | In distribution |
| 14-563645 | Device Size Text, specify—POL4.75 CLOSED MAS 7.0X45MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-584522 | Device Size Text, specify—4.75 TI 6.5X22.5MM FIXED SCREW | In distribution |
| 14-585330CL | Device Size Text, specify—4.5X300MM COCR LOW LS CRV ROD | In distribution |
| 14-589099 | In distribution | |
| 14-588551CL | Device Size Text, specify—4.75/5.5X510MM COCR LOW ROD | In distribution |
| 14-581845 | In distribution | |
| 14-589308 | In distribution | |
| 14-562727 | Device Size Text, specify—POL4.75 OPEN MAS 7.5X27.5MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-563680 | Device Size Text, specify—POL4.75 CLOSED MAS 7.0X80MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-584855 | Device Size Text, specify—4.75 TI 8.5X55MM FIXED SCREW | In distribution |
| 14-587313CH | Device Size Text, specify—4.75X130MM COCR HI LS CRV ROD | In distribution |
| 14-584595 | Device Size Text, specify—4.75 TI 6.5X95MM FIXED SCREW | In distribution |
| 14-587151CS | In distribution | |
| 14-562246 | Device Size Text, specify—POL4.75 OPEN MAS 5.0X130MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-562340 | In distribution | |
| 14-563980 | Device Size Text, specify—POL4.75 CLOSED MAS 9.5X80MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-581550 | Device Size Text, specify—4.75 TI 5MM REDUC LAM HOOK | In distribution |
| 14-584480 | Device Size Text, specify—4.75 TI 6.0X80MM FIXED SCREW | In distribution |
| 14-584475 | Device Size Text, specify—4.75 TI 6.0X75MM FIXED SCREW | In distribution |
| 14-563961 | Device Size Text, specify—POL4.75 CLOSED MAS 10.5X60MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-584580 | Device Size Text, specify—4.75 TI 6.5X80MM FIXED SCREW | In distribution |
| 14-586530T | Device Size Text, specify—4.5/5.5X300MM TI ALLOY ROD | In distribution |
| 14-562055 | Device Size Text, specify—POL4.75 OPEN MAS 4.0X55MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-586545CH | Device Size Text, specify—4.5/5.5X450MM COCR HIGH ROD | In distribution |
| 14-562021 | Device Size Text, specify—POL4.75 OPEN MAS 4.0X105MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-562155 | Device Size Text, specify—POL4.75 OPEN MAS 4.5X55MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-584971 | Device Size Text, specify—4.75 TI 10.5X70MM FIXED SCREW | In distribution |
| 14-585103T | Device Size Text, specify—4.5X30MM TI ALLOY HEX ROD | In distribution |
| 14-562421 | Device Size Text, specify—POL4.75 OPEN MAS 6.0X105MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-562266 | Device Size Text, specify—POL4.75 OPEN MAS 5.0X150MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-589210 | In distribution | |
| 14-587245CH | Device Size Text, specify—4.75X450MM COCR HI MR CRV ROD | In distribution |
| 14-562620 | Device Size Text, specify—POL4.75 OPEN MAS 7.0X20MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-584540 | Device Size Text, specify—4.75 TI 6.5X40MM FIXED SCREW | In distribution |
| 14-562175 | Device Size Text, specify—POL4.75 OPEN MAS 4.5X75MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-584461 | Device Size Text, specify—4.75 TI 6.0X145MM FIXED SCREW | In distribution |
| 14-562755 | Device Size Text, specify—POL4.75 OPEN MAS 7.5X55MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-584840 | Device Size Text, specify—4.75 TI 8.5X40MM FIXED SCREW | In distribution |
| 14-562880 | Device Size Text, specify—POL4.75 OPEN MAS 8.5X80MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-563690 | Device Size Text, specify—POL4.75 CLOSED MAS 7.0X90MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-584555 | Device Size Text, specify—4.75 TI 6.5X55MM FIXED SCREW | In distribution |
| 14-584561 | Device Size Text, specify—4.75 TI 6.5X145MM FIXED SCREW | In distribution |
| 14-584931 | Device Size Text, specify—4.75 TI 10.5X30MM FIXED SCREW | In distribution |
| 14-584730 | Device Size Text, specify—4.75 TI 7.5X30MM FIXED SCREW | In distribution |
| 14-562225 | In distribution | |
| 14-563938 | Device Size Text, specify—POL4.75 CLOSED MAS 10.5X120MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-584456 | Device Size Text, specify—4.75 TI 6.0X140MM FIXED SCREW | In distribution |
| 14-584940 | Device Size Text, specify—4.75 TI 9.5X40MM FIXED SCREW | In distribution |
| 14-584626 | Device Size Text, specify—4.75 TI 7.0X110MM FIXED SCREW | In distribution |
| 14-584926 | Device Size Text, specify—4.75 TI 10.5X25MM FIXED SCREW | In distribution |
| 14-585251CL | Device Size Text, specify—4.5X510MM COCR LOW MR CRV ROD | In distribution |
| 14-587103CS | Device Size Text, specify—4.75X30MM COCR STD HEX ROD | In distribution |
| 14-584944 | Device Size Text, specify—4.75 TI 10.5X125MM FIXED SCREW | In distribution |
| 14-562180 | Device Size Text, specify—POL4.75 OPEN MAS 4.5X80MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-562820 | Device Size Text, specify—POL4.75 OPEN MAS 8.5X20MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-584531 | Device Size Text, specify—4.75 TI 6.5X115MM FIXED SCREW | In distribution |
| 14-586530CL | Device Size Text, specify—4.5/5.5X300MM COCR LOW ROD | In distribution |
| 14-584521 | Device Size Text, specify—4.75 TI 6.5X105MM FIXED SCREW | In distribution |
| 14-587160T | Device Size Text, specify—4.75X600MM TI ALLOY HEX ROD | In distribution |
| 14-585245CL | Device Size Text, specify—4.5X450MM COCR LOW MR CRV ROD | In distribution |
| 14-562095 | Device Size Text, specify—POL4.75 OPEN MAS 4.0X95MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-562420 | Device Size Text, specify—POLARIS 4.75 6.0MM X 20MM Multiaxial Screw | In distribution |
| 14-587151T | Device Size Text, specify—4.75X510MM TI ALLOY HEX ROD | In distribution |
| 14-584736 | Device Size Text, specify—4.75 TI 7.5X120MM FIXED SCREW | In distribution |
| 14-562725 | Device Size Text, specify—POL4.75 OPEN MAS 7.5X25MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-563646 | Device Size Text, specify—POL4.75 CLOSED MAS 7.0X130MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-584827 | Device Size Text, specify—4.75 TI 8.5X27.5MM FIXED SCREW | In distribution |
| 14-584954 | Device Size Text, specify—4.75 TI 10.5X135MM FIXED SCREW | In distribution |
| 14-562090 | Device Size Text, specify—POL4.75 OPEN MAS 4.0X90MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-585313CL | Device Size Text, specify—4.5X130MM COCR LOW LS CRV ROD | In distribution |
| 14-584420 | Device Size Text, specify—4.75 TI 6.0X20MM FIXED SCREW | In distribution |
| 14-584948 | Device Size Text, specify—4.75 TI 10.5X130MM FIXED SCREW | In distribution |
| 14-584675 | Device Size Text, specify—4.75 TI 7.0X75MM FIXED SCREW | In distribution |
| 14-562127 | In distribution | |
| 14-587145T | Device Size Text, specify—4.75X450MM TI ALLOY HEX ROD | In distribution |
| 14-585313T | Device Size Text, specify—4.5X130MM TI ALLOY LS CRV ROD | In distribution |
| 14-584646 | Device Size Text, specify—4.75 TI 7.0X130MM FIXED SCREW | In distribution |
| 14-562041 | Device Size Text, specify—POL4.75 OPEN MAS 4.0X125MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-584585 | Device Size Text, specify—4.75 TI 6.5X85MM FIXED SCREW | In distribution |
| 14-585330CS | Device Size Text, specify—4.5X300MM COCR STD LS CRV ROD | In distribution |
| 14-587260T | Device Size Text, specify—4.75X600MM TI ALLOY MR CRV ROD | In distribution |
| 14-587245T | Device Size Text, specify—4.75X450MM TI ALLOY MR CRV ROD | In distribution |
| 14-581660L | In distribution | |
| 14-585103CL | Device Size Text, specify—4.5X30MM COCR LOW HEX ROD | In distribution |
| 14-562425 | Device Size Text, specify—POLARIS 4.75 6.0MM X 25MM Multiaxial Screw | In distribution |
| 14-563970 | Device Size Text, specify—POL4.75 CLOSED MAS 9.5X70MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-584924 | Device Size Text, specify—4.75 TI 9.5X105MM FIXED SCREW | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-07-30 | Class II | Nonconforming Material/Component | The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications | 16,429 devices (Thoracolumbosacral pedicle screw system,Spin | 2021-04-28 |
| 2015-07-22 | Class II | Device Design | Biomet has initiated a recall on Biomet Spine Lineum OCC Starter Flexible and its inner shaft instrumentsafter identifying that these instruments were distributed prior to completion of all design control activities. | 49 | 2015-12-10 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.