Polaris™ 4.75 Spinal System
458 catalogue numbers from 14-563295, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Interlaminal. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
458catalogue numbers in this listing
1510(k) clearance
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 | Biomet Spine, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Record published | 2020-06-25 |
| Record revised | 2025-07-02 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-563295 | 4.75 CLOSED MAS closed MAS 5.0X95MM Closed Head Multiaxial Screw | In distribution |
| 14-562846 | POL4.75 Open MAS 8.5X130MM Multiaxial Screw | In distribution |
| 14-589704 | 4.75 TI OFFSET CONNECTOR, LG | In distribution |
| 14-584948 | 4.75 TI 10.5X130MM FIXED SCREW FIXED SCREW | In distribution |
| 14-562727 | POL4.75 Open MAS 7.5X27.5MM Multiaxial Screw | In distribution |
| 14-563931 | POL4.75 CLOSED MAS 10.5X30MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-583840 | 4.75 TI 8.5X40MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-582441 | 4.75 TI 6.0X125MM MAS MULTIAXIAL SCREW | In distribution |
| 14-589703R | 4.75 TI RIGHT OFFSET CONN, M RIGHT OFFSET CONNECTOR | In distribution |
| 14-562126 | POL4.75 OPEN MAS 4.5X110MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-582335 | 4.75 TI 5.5X35MM MAS MULTIAXIAL SCREW | In distribution |
| 14-583945 | 4.75 TI 9.5X45MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-582130 | 4.75 TI 4.5X30MM MAS MULTIAXIAL SCREW | In distribution |
| 14-563140 | 4.75 CLOSED MAS closed MAS 4.5X40MM Closed Head Multiaxial Screw | In distribution |
| 14-582720 | 4.75 TI 7.5X20MM MAS MULTIAXIAL SCREW | In distribution |
| 14-562755 | POL4.75 OPEN MAS 7.5X55MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-582236 | 4.75 TI 5.0X120MM MAS MULTIAXIAL SCREW | In distribution |
| 14-563621 | POL4.75 CLOSED MAS 7.0X105MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-584175 | 4.75 TI 4.5X75MM FIXED SCREW FIXED SCREW | In distribution |
| 14-562991 | POL4.75 OPEN MAS 10.5X90MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-587351CH | 4.75X510MM COCR HI LS CRV ROD FOR LESS CURVED CONNECTOR | In distribution |
| 14-583685 | 4.75 TI 7.0X85MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-563933 | POL4.75 Closed MAS 9.5X115MM Closed Head Multiaxial Screw | In distribution |
| 14-589713 | 4.75 TI OFFSET CONNECTOR, 35MM | In distribution |
| 14-562495 | POL4.75 Open MAS 6.0X95MM Multiaxial Screw | In distribution |
| 14-562967 | POL4.75 Open MAS 9.5X150MM Multiaxial Screw | In distribution |
| 14-581460 | 4.75 TI LARGE LAMINAR HOOK LARGE LAMINAR HOOK | In distribution |
| 14-587213CL | 4.75X130MM COCR LOW MR CRV ROD FOR MORE CURVED CONNECTOR | In distribution |
| 14-585213CL | 4.5X130MM COCR LOW MR CRV ROD FOR MORE CURVED CONNECTOR | In distribution |
| 14-563451 | 4.75 CLOSED MAS CLOSED MAS 6.0X135MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-583920 | 4.75 TI 9.5X20MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-587145CH | 4.75X450MM COCR HIGH HEX ROD STRAIGHT | In distribution |
| 14-583755 | 4.75 TI 7.5X55MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-583222 | 4.75 TI 5.0X22.5MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-563971 | POL4.75 Closed MAS 10.5X70MM Closed Head Multiaxial Screw | In distribution |
| 14-584970 | 4.75 TI 9.5X70MM FIXED SCREW FIXED SCREW | In distribution |
| 14-563045 | 4.75 CLOSED MAS closed MAS 4.0X45MM Closed Head Multiaxial Screw | In distribution |
| 14-562099 | POL4.75 OPEN MAS 4.0X100MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-581745 | 4.75 TI MEDIUM ANG BLADE HOOK ANGLED BLADE HOOK | In distribution |
| 14-563926 | POL4.75 CLOSED MAS 10.5X25MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-584250 | 4.75 TI 5.0X50MM FIXED SCREW FIXED SCREW | In distribution |
| 14-583740 | 4.75 TI 7.5X40MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-563490 | 4.75 CLOSED MAS closed MAS 6.0X90MM Closed Head Multiaxial Screw | In distribution |
| 14-582661 | 4.75 TI 7.0X145MM MAS MULTIAXIAL SCREW | In distribution |
| 14-584526 | 4.75 TI 6.5X110MM FIXED SCREW FIXED SCREW | In distribution |
| 14-582599 | 4.75 TI 6.5X100MM MAS MULTIAXIAL SCREW | In distribution |
| 14-562366 | POL4.75 Open MAS 5.5X150MM Multiaxial Screw | In distribution |
| 14-587151CS | 4.75X510MM COCR STD HEX ROD STRAIGHT | In distribution |
| 14-584932 | 4.75 TI 10.5X105MM FIXED SCREW FIXED SCREW | In distribution |
| 14-562736 | POL4.75 Open MAS 7.5X120MM Multiaxial Screw | In distribution |
| 14-583957 | 4.75 TI 9.5X140MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-584230 | 4.75 TI 5.0X30MM FIXED SCREW FIXED SCREW | In distribution |
| 14-584560 | 4.75 TI 6.5X60MM FIXED SCREW FIXED SCREW | In distribution |
| 14-582827 | 4.75 TI 8.5X27.5MM MAS MULTIAXIAL SCREW | In distribution |
| 14-581690L | 4.75 TI 9MM LEFT OFFSET HOOK | In distribution |
| 14-583765 | 4.75 TI 7.5X65MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-583856 | 4.75 TI 8.5X140MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-587130CL | 4.75X300MM COCR LOW HEX ROD STRAIGHT | In distribution |
| 14-562561 | POL4.75 Open MAS 6.5X145MM Multiaxial Screw | In distribution |
| 14-562260 | POL4.75 Open MAS 5.0X60MM Multiaxial Screw | In distribution |
| 14-563220 | 4.75 CLOSED MAS closed MAS 5.0X20MM Closed Head Multiaxial Screw | In distribution |
| 14-562399 | POL4.75 Open MAS 5.5X100MM Multiaxial Screw | In distribution |
| 14-562055 | POL4.75 OPEN MAS 4.0X55MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-580912N | 4.75TI 12.5MM UNIV HK NO SPIKE 12.5MM UNIVERSAL HOOK | In distribution |
| 14-563130 | 4.75 CLOSED MAS CLOSED MAS 4.5X30MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-580907 | 4.75 TI 6.5MM UNIVERSAL HOOK | In distribution |
| 14-563699 | POL4.75 CLOSED MAS 7.0X100MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-582750 | 4.75 TI 7.5X50MM MAS MULTIAXIAL SCREW | In distribution |
| 14-562245 | POLARIS 4.75 5.0MM X 45MM Multiaxial Screw | In distribution |
| 14-582735 | 4.75 TI 7.5X35MM MAS MULTIAXIAL SCREW | In distribution |
| 14-562923 | POL4.75 OPEN MAS 10.5X22.5MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-582625 | 4.75 TI 7.0X25MM MAS MULTIAXIAL SCREW | In distribution |
| 14-582799 | 4.75 TI 7.5X100MM MAS MULTIAXIAL SCREW | In distribution |
| 14-584520 | 4.75 TI 6.5X20MM FIXED SCREW FIXED SCREW | In distribution |
| 14-563250 | 4.75 CLOSED MAS closed MAS 5.0X50MM Closed Head Multiaxial Screw | In distribution |
| 14-562836 | POL4.75 Open MAS 8.5X120MM Multiaxial Screw | In distribution |
| 14-584130 | 4.75 TI 4.5X30MM FIXED SCREW FIXED SCREW | In distribution |
| 14-583566 | 4.75 TI 6.5X150MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-582975 | 4.75 TI 9.5X75MM MAS MULTIAXIAL SCREW | In distribution |
| 14-583040 | 4.75 TI 4.0X40MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-585145CL | 4.5X450MM COCR LOW HEX ROD STRAIGHT | In distribution |
| 14-563027 | 4.75 CLOSED MAS closed MAS 4.0X27.5MM Closed Head Multiaxial Screw | In distribution |
| 14-562455 | POL4.75 Open MAS 6.0X55MM Multiaxial Screw | In distribution |
| 14-562963 | POL4.75 Open MAS 9.5X145MM Multiaxial Screw | In distribution |
| 14-583051 | 4.75 TI 4.0X135MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-562251 | POL4.75 Open MAS 5.0X135MM Multiaxial Screw | In distribution |
| 14-583495 | 4.75 TI 6.0X95MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-563480 | 4.75 CLOSED MAS closed MAS 6.0X80MM Closed Head Multiaxial Screw | In distribution |
| 14-581590 | 4.75 TI 9MM REDUC LAM HOOK REDUCED LAMINAR HOOK | In distribution |
| 14-584525 | 4.75 TI 6.5X25MM FIXED SCREW FIXED SCREW | In distribution |
| 14-563061 | 4.75 CLOSED MAS closed MAS 4.0X145MM Closed Head Multiaxial Screw | In distribution |
| 14-562960 | POL4.75 Open MAS 9.5X60MM Multiaxial Screw | In distribution |
| 14-584327 | 4.75 TI 5.5X27.5MM FIXED SCREW FIXED SCREW | In distribution |
| 14-589210 | 4.75 TI 100MM MORE CRV AX CONN MORE CURVED AXIAL CONNECTOR | In distribution |
| 14-582722 | 4.75 TI 7.5X22.5MM MAS MULTIAXIAL SCREW | In distribution |
| 14-563536 | 4.75 CLOSED MAS closed MAS 6.5X120MM Closed Head Multiaxial Screw | In distribution |
| 14-582996 | 4.75 TI 10.5X95MM MAS MULTIAXIAL SCREW | In distribution |
| 14-582466 | 4.75 TI 6.0X150MM MAS MULTIAXIAL SCREW | In distribution |
| 14-563261 | 4.75 CLOSED MAS CLOSED MAS 5.0X145MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-584924 | 4.75 TI 9.5X105MM FIXED SCREW FIXED SCREW | In distribution |
| 14-584540 | 4.75 TI 6.5X40MM FIXED SCREW FIXED SCREW | In distribution |
| 14-562527 | POLARIS 4.75 6.5MM X 27.5MM Multiaxial Screw | In distribution |
| 14-585330CL | 4.5X300MM COCR LOW LS CRV ROD FOR LESS CURVED CONNECTOR | In distribution |
| 14-584141 | 4.75 TI 4.5X125MM FIXED SCREW FIXED SCREW | In distribution |
| 14-563421 | 4.75 CLOSED MAS closed MAS 6.0X105MM Closed Head Multiaxial Screw | In distribution |
| 14-588530CH | 4.75/5.5X300MM COCR HIGH ROD TRANSITION | In distribution |
| 14-583346 | 4.75 TI 5.5X130MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-562831 | POL4.75 Open MAS 8.5X115MM Multiaxial Screw | In distribution |
| 14-563030 | 4.75 CLOSED MAS closed MAS 4.0X30MM Closed Head Multiaxial Screw | In distribution |
| 14-562566 | POL4.75 OPEN MAS 6.5X150MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-582531 | 4.75 TI 6.5X115MM MAS MULTIAXIAL SCREW | In distribution |
| 14-582770 | 4.75 TI 7.5X70MM MAS MULTIAXIAL SCREW | In distribution |
| 14-583060 | 4.75 TI 4.0X60MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-562480 | POL4.75 OPEN MAS 6.0X80MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-587230CH | 4.75X300MM COCR HI MR CRV ROD FOR MORE CURVED CONNECTOR | In distribution |
| 14-582060 | 4.75 TI 4.0X60MM MAS MULTIAXIAL SCREW | In distribution |
| 14-584195 | 4.75 TI 4.5X95MM FIXED SCREW FIXED SCREW | In distribution |
| 14-585151T | 4.5X510MM TI ALLOY HEX ROD STRAIGHT | In distribution |
| 14-589518 | 4.75 TI 18MM FIXED CROSS CONN FIXED CROSS CONNECTOR | In distribution |
| 14-587130CS | 4.75X300MM COCR STD HEX ROD STRAIGHT | In distribution |
| 14-583780 | 4.75 TI 7.5X80MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-587360CL | 4.75X600MM COCR LOW LS CRV ROD FOR LESS CURVED CONNECTOR | In distribution |
| 14-562665 | POL4.75 Open MAS 7.0X65MM Multiaxial Screw | In distribution |
| 14-583022 | 4.75 TI 4.0X22.5MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-580907N | 4.75 TI 6.5MM UNIV HK NO SPIKE 6.5MM UNIVERSAL HOOK | In distribution |
| 14-582933 | 4.75 TI 9.5X115MM MAS MULTIAXIAL SCREW | In distribution |
| 14-584822 | 4.75 TI 8.5X22.5MM FIXED SCREW FIXED SCREW | In distribution |
| 14-562695 | POL4.75 OPEN MAS 7.0X95MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-581050 | 4.75 TI 5MM MIDSTEM HOOK | In distribution |
| 14-582541 | 4.75 TI 6.5X125MM MAS MULTIAXIAL SCREW | In distribution |
| 14-562550 | POLARIS 4.75 6.5MM X 50MM Multiaxial Screw | In distribution |
| 14-562251 | POL4.75 OPEN MAS 5.0X135MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-583963 | 4.75 TI 9.5X145MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-584721 | 4.75 TI 7.5X105MM FIXED SCREW FIXED SCREW | In distribution |
| 14-583250 | 4.75 TI 5.0X50MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-563546 | 4.75 CLOSED MAS closed MAS 6.5X130MM Closed Head Multiaxial Screw | In distribution |
| 14-582061 | 4.75 TI 4.0X145MM MAS MULTIAXIAL SCREW | In distribution |
| 14-583921 | 4.75 TI 10.5X20MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-563980 | POL4.75 CLOSED MAS 9.5X80MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-562946 | POL4.75 Open MAS 10.5X45MM Multiaxial Screw | In distribution |
| 14-589715 | 4.75 TI OFFSET CONNECTOR, 50MM | In distribution |
| 14-584927 | 4.75 TI 9.5X27.5MM FIXED SCREW FIXED SCREW | In distribution |
| 14-584236 | 4.75 TI 5.0X120MM FIXED SCREW FIXED SCREW | In distribution |
| 14-584266 | 4.75 TI 5.0X150MM FIXED SCREW FIXED SCREW | In distribution |
| 14-584641 | 4.75 TI 7.0X125MM FIXED SCREW FIXED SCREW | In distribution |
| 14-583855 | 4.75 TI 8.5X55MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-587251CL | 4.75X510MM COCR LOW MR CRV ROD FOR MORE CURVED CONNECTOR | In distribution |
| 14-583070 | 4.75 TI 4.0X70MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-582944 | 4.75 TI 10.5X125MM MAS MULTIAXIAL SCREW | In distribution |
| 14-563946 | POL4.75 Closed MAS 10.5X45MM Closed Head Multiaxial Screw | In distribution |
| 14-563675 | POL4.75 Closed MAS 7.0X75MM Closed Head Multiaxial Screw | In distribution |
| 14-585103CS | 4.5X30MM COCR STD HEX ROD STRAIGHT | In distribution |
| 14-585160CH | 4.5X600MM COCR HIGH HEX ROD STRAIGHT | In distribution |
| 14-589799 | 4.75 TI OPEN CONN SET SCREW FOR OPEN CONNECTORS/C-CLAMP | In distribution |
| 14-563431 | 4.75 CLOSED MAS closed MAS 6.0X115MM Closed Head Multiaxial Screw | In distribution |
| 14-584765 | 4.75 TI 7.5X65MM FIXED SCREW FIXED SCREW | In distribution |
| 14-583675 | 4.75 TI 7.0X75MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-583195 | 4.75 TI 4.5X95MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-582731 | 4.75 TI 7.5X115MM MAS MULTIAXIAL SCREW | In distribution |
| 14-584561 | 4.75 TI 6.5X145MM FIXED SCREW FIXED SCREW | In distribution |
| 14-563185 | 4.75 CLOSED MAS closed MAS 4.5X85MM Closed Head Multiaxial Screw | In distribution |
| 14-563351 | 4.75 CLOSED MAS closed MAS 5.5X135MM Closed Head Multiaxial Screw | In distribution |
| 14-582255 | 4.75 TI 5.0X55MM MAS MULTIAXIAL SCREW | In distribution |
| 14-562655 | POL4.75 Open MAS 7.0X55MM Multiaxial Screw | In distribution |
| 14-583996 | 4.75 TI 10.5X95MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-583341 | 4.75 TI 5.5X125MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-583944 | 4.75 TI 10.5X125MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-563551 | 4.75 CLOSED MAS closed MAS 6.5X135MM Closed Head Multiaxial Screw | In distribution |
| 14-584336 | 4.75 TI 5.5X120MM FIXED SCREW FIXED SCREW | In distribution |
| 14-563170 | 4.75 CLOSED MAS CLOSED MAS 4.5X70MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-562595 | POL4.75 OPEN MAS 6.5X95MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-585160T | 4.5X600MM TI ALLOY HEX ROD STRAIGHT | In distribution |
| 14-563938 | POL4.75 CLOSED MAS 10.5X120MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-563841 | POL4.75 Closed MAS 8.5X125MM Closed Head Multiaxial Screw | In distribution |
| 14-585113CS | 4.5X130MM COCR STD HEX ROD STRAIGHT | In distribution |
| 14-563755 | POL4.75 Closed MAS 7.5X55MM Closed Head Multiaxial Screw | In distribution |
| 14-582931 | 4.75 TI 10.5X30MM MAS MULTIAXIAL SCREW | In distribution |
| 14-589835 | 4.75 TI 35MM BRIDGE CONN BRIDGE CONNECTOR, 5.5MM POST | In distribution |
| 14-583927 | 4.75 TI 9.5X27.5MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-585113T | 4.5X130MM TI ALLOY HEX ROD STRAIGHT | In distribution |
| 14-581060 | 4.75 TI LARGE MIDSTEM HOOK | In distribution |
| 14-563441 | 4.75 CLOSED MAS CLOSED MAS 6.0X125MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-562061 | POL4.75 Open MAS 4.0X145MM Multiaxial Screw | In distribution |
| 14-587230CS | 4.75X300MM COCR STD MR CRV ROD FOR MORE CURVED CONNECTOR | In distribution |
| 14-583531 | 4.75 TI 6.5X115MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-563190 | 4.75 CLOSED MAS CLOSED MAS 4.5X90MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-583122 | 4.75 TI 4.5X22.5MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-589106 | 4.75 TI 60MM STRGT AXIAL CONN STRAIGHT AXIAL CONNECTOR | In distribution |
| 14-563861 | POL4.75 CLOSED MAS 8.5X145MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-587245T | 4.75X450MM TI ALLOY MR CRV ROD FOR MORE CURVED CONNECTOR | In distribution |
| 14-587160CH | 4.75X600MM COCR HIGH HEX ROD STRAIGHT | In distribution |
| 14-582951 | 4.75 TI 10.5X50MM MAS MULTIAXIAL SCREW | In distribution |
| 14-584885 | 4.75 TI 8.5X85MM FIXED SCREW FIXED SCREW | In distribution |
| 14-584450 | 4.75 TI 6.0X50MM FIXED SCREW FIXED SCREW | In distribution |
| 14-584860 | 4.75 TI 8.5X60MM FIXED SCREW FIXED SCREW | In distribution |
| 14-562726 | POL4.75 Open MAS 7.5X110MM Multiaxial Screw | In distribution |
| 14-562981 | POL4.75 Open MAS 10.5X80MM Multiaxial Screw | In distribution |
| 14-583435 | 4.75 TI 6.0X35MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-584820 | 4.75 TI 8.5X20MM FIXED SCREW FIXED SCREW | In distribution |
| 14-562026 | POL4.75 OPEN MAS 4.0X110MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-583890 | 4.75 TI 8.5X90MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-583580 | 4.75 TI 6.5X80MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-586560CS | 4.5/5.5X600MM COCR STD ROD TRANSITION | In distribution |
| 14-584436 | 4.75 TI 6.0X120MM FIXED SCREW FIXED SCREW | In distribution |
| 14-562225 | POLARIS 4.75 5.0MM X 25MM Multiaxial Screw | In distribution |
| 14-562841 | POL4.75 Open MAS 8.5X125MM Multiaxial Screw | In distribution |
| 14-563355 | 4.75 CLOSED MAS closed MAS 5.5X55MM Closed Head Multiaxial Screw | In distribution |
| 14-583255 | 4.75 TI 5.0X55MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-582875 | 4.75 TI 8.5X75MM MAS MULTIAXIAL SCREW | In distribution |
| 14-562938 | POL4.75 OPEN MAS 10.5X120MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-582227 | 4.75 TI 5.0X27.5MM MAS MULTIAXIAL SCREW | In distribution |
| 14-584961 | 4.75 TI 10.5X60MM FIXED SCREW FIXED SCREW | In distribution |
| 14-584730 | 4.75 TI 7.5X30MM FIXED SCREW FIXED SCREW | In distribution |
| 14-582320 | 4.75 TI 5.5X20MM MAS MULTIAXIAL SCREW | In distribution |
| 14-582995 | 4.75 TI 9.5X95MM MAS MULTIAXIAL SCREW | In distribution |
| 14-583036 | 4.75 TI 4.0X120MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-562635 | POL4.75 Open MAS 7.0X35MM Multiaxial Screw | In distribution |
| 14-584960 | 4.75 TI 9.5X60MM FIXED SCREW FIXED SCREW | In distribution |
| 14-562250 | POLARIS 4.75 5.0MM X 50MM Multiaxial Screw | In distribution |
| 14-563621 | POL4.75 Closed MAS 7.0X105MM Closed Head Multiaxial Screw | In distribution |
| 14-583727 | 4.75 TI 7.5X27.5MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-583425 | 4.75 TI 6.0X25MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-582585 | 4.75 TI 6.5X85MM MAS MULTIAXIAL SCREW | In distribution |
| 14-562622 | POL4.75 OPEN MAS 7.0X22.5MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-563035 | 4.75 CLOSED MAS closed MAS 4.0X35MM Closed Head Multiaxial Screw | In distribution |
| 14-582270 | 4.75 TI 5.0X70MM MAS MULTIAXIAL SCREW | In distribution |
| 14-562740 | POL4.75 Open MAS 7.5X40MM Multiaxial Screw | In distribution |
| 14-583130 | 4.75 TI 4.5X30MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-583231 | 4.75 TI 5.0X115MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-582175 | 4.75 TI 4.5X75MM MAS MULTIAXIAL SCREW | In distribution |
| 14-562961 | POL4.75 Open MAS 10.5X60MM Multiaxial Screw | In distribution |
| 14-562170 | POL4.75 Open MAS 4.5X70MM Multiaxial Screw | In distribution |
| 14-582156 | 4.75 TI 4.5X140MM MAS MULTIAXIAL SCREW | In distribution |
| 14-584954 | 4.75 TI 10.5X135MM FIXED SCREW FIXED SCREW | In distribution |
| 14-582934 | 4.75 TI 10.5X115MM MAS MULTIAXIAL SCREW | In distribution |
| 14-562946 | POL4.75 OPEN MAS 10.5X45MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-563199 | 4.75 CLOSED MAS CLOSED MAS 4.5X100MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-584990 | 4.75 TI 9.5X90MM FIXED SCREW FIXED SCREW | In distribution |
| 14-563956 | POL4.75 CLOSED MAS 10.5X55MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-562541 | POL4.75 Open MAS 6.5X125MM Multiaxial Screw | In distribution |
| 14-581750 | 4.75 TI 5MM ANG BLADE HOOK ANGLED BLADE HOOK | In distribution |
| 14-563963 | POL4.75 Closed MAS 9.5X145MM Closed Head Multiaxial Screw | In distribution |
| 14-584460 | 4.75 TI 6.0X60MM FIXED SCREW FIXED SCREW | In distribution |
| 14-562986 | POL4.75 OPEN MAS 10.5X85MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-583061 | 4.75 TI 4.0X145MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-581550 | 4.75 TI 5MM REDUC LAM HOOK REDUCED LAMINAR HOOK | In distribution |
| 14-583420 | 4.75 TI 6.0X20MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-563231 | 4.75 CLOSED MAS CLOSED MAS 5.0X115MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-562090 | POL4.75 Open MAS 4.0X90MM Multiaxial Screw | In distribution |
| 14-562885 | POL4.75 OPEN MAS 8.5X85MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K071377 | 2007-08-06 |
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.