Polaris™ 4.75 Spinal System
438 catalogue numbers from 14-563880, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
438catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| 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 |
|---|---|---|
| 14-563880 | POL4.75 Closed MAS 8.5X80MM Closed Head Multiaxial Screw | In distribution |
| 14-583526 | 4.75 TI 6.5X110MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-584456 | 4.75 TI 6.0X140MM FIXED SCREW FIXED SCREW | In distribution |
| 14-563190 | 4.75 CLOSED MAS closed MAS 4.5X90MM Closed Head Multiaxial Screw | In distribution |
| 14-563856 | POL4.75 Closed MAS 8.5X140MM Closed Head Multiaxial Screw | In distribution |
| 14-563631 | POL4.75 Closed MAS 7.0X115MM Closed Head Multiaxial Screw | In distribution |
| 14-582641 | 4.75 TI 7.0X125MM MAS MULTIAXIAL SCREW | In distribution |
| 14-562270 | POL4.75 Open MAS 5.0X70MM Multiaxial Screw | In distribution |
| 14-562924 | POL4.75 OPEN MAS 9.5X105MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-582965 | 4.75 TI 9.5X65MM MAS MULTIAXIAL SCREW | In distribution |
| 14-563240 | 4.75 CLOSED MAS closed MAS 5.0X40MM Closed Head Multiaxial Screw | In distribution |
| 14-581240L | 4.75 TI 4MM LEFT ANGLED HOOK | In distribution |
| 14-563957 | POL4.75 Closed MAS 9.5X140MM Closed Head Multiaxial Screw | In distribution |
| 14-562431 | POL4.75 Open MAS 6.0X115MM Multiaxial Screw | In distribution |
| 14-562680 | POL4.75 Open MAS 7.0X80MM Multiaxial Screw | In distribution |
| 14-563420 | 4.75 CLOSED MAS closed MAS 6.0X20MM Closed Head Multiaxial Screw | In distribution |
| 14-562945 | POL4.75 Open MAS 9.5X45MM Multiaxial Screw | In distribution |
| 14-584385 | 4.75 TI 5.5X85MM FIXED SCREW FIXED SCREW | In distribution |
| 14-584222 | 4.75 TI 5.0X22.5MM FIXED SCREW FIXED SCREW | In distribution |
| 14-581760 | 4.75 TI LARGE ANG BLADE HOOK ANGLED BLADE HOOK | In distribution |
| 14-562241 | POL4.75 Open MAS 5.0X125MM Multiaxial Screw | In distribution |
| 14-587260CS | 4.75X600MM COCR STD MR CRV ROD FOR MORE CURVED CONNECTOR | In distribution |
| 14-562051 | POL4.75 Open MAS 4.0X135MM Multiaxial Screw | In distribution |
| 14-563575 | 4.75 CLOSED MAS closed MAS 6.5X75MM Closed Head Multiaxial Screw | In distribution |
| 14-562585 | POL4.75 Open MAS 6.5X85MM Multiaxial Screw | In distribution |
| 14-562981 | POL4.75 OPEN MAS 10.5X80MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-562380 | POL4.75 Open MAS 5.5X80MM Multiaxial Screw | In distribution |
| 14-562970 | POL4.75 Open MAS 9.5X70MM Multiaxial Screw | In distribution |
| 14-583565 | 4.75 TI 6.5X65MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-581290L | 4.75 TI 9MM LEFT ANGLED HOOK | In distribution |
| 14-584366 | 4.75 TI 5.5X150MM FIXED SCREW FIXED SCREW | In distribution |
| 14-562150 | POLARIS 4.75 4.5MM X 50MM Multiaxial Screw | In distribution |
| 14-583335 | 4.75 TI 5.5X35MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-583922 | 4.75 TI 9.5X22.5MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-582290 | 4.75 TI 5.0X90MM MAS MULTIAXIAL SCREW | In distribution |
| 14-563799 | POL4.75 Closed MAS 7.5X100MM Closed Head Multiaxial Screw | In distribution |
| 14-585103CH | 4.5X30MM COCR HIGH HEX ROD STRAIGHT | In distribution |
| 14-562980 | POL4.75 Open MAS 9.5X80MM Multiaxial Screw | In distribution |
| 14-587103CL | 4.75X30MM COCR LOW HEX ROD STRAIGHT | In distribution |
| 14-582455 | 4.75 TI 6.0X55MM MAS MULTIAXIAL SCREW | In distribution |
| 14-562520 | POLARIS 4.75 6.5MM X 20MM Multiaxial Screw | In distribution |
| 14-563821 | POL4.75 Closed MAS 8.5X105MM Closed Head Multiaxial Screw | In distribution |
| 14-563095 | 4.75 CLOSED MAS CLOSED MAS 4.0X95MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-563860 | POL4.75 CLOSED MAS 8.5X60MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-582785 | 4.75 TI 7.5X85MM MAS MULTIAXIAL SCREW | In distribution |
| 14-583968 | 4.75 TI 10.5X150MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-583745 | 4.75 TI 7.5X45MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-563327 | 4.75 CLOSED MAS closed MAS 5.5X27.5MM Closed Head Multiaxial Screw | In distribution |
| 14-562556 | POL4.75 OPEN MAS 6.5X140MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-583260 | 4.75 TI 5.0X60MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-562041 | POL4.75 Open MAS 4.0X125MM Multiaxial Screw | In distribution |
| 14-562421 | POL4.75 OPEN MAS 6.0X105MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-582845 | 4.75 TI 8.5X45MM MAS MULTIAXIAL SCREW | In distribution |
| 14-584620 | 4.75 TI 7.0X20MM FIXED SCREW FIXED SCREW | In distribution |
| 14-563495 | 4.75 CLOSED MAS CLOSED MAS 6.0X95MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-562954 | POL4.75 OPEN MAS 10.5X135MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-583026 | 4.75 TI 4.0X110MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-562895 | POL4.75 Open MAS 8.5X95MM Multiaxial Screw | In distribution |
| 14-563822 | POL4.75 CLOSED MAS 8.5X22.5MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-563456 | 4.75 CLOSED MAS closed MAS 6.0X140MM Closed Head Multiaxial Screw | In distribution |
| 14-563026 | 4.75 CLOSED MAS CLOSED MAS 4.0X110MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-583356 | 4.75 TI 5.5X140MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-562351 | POL4.75 OPEN MAS 5.5X135MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-563670 | POL4.75 Closed MAS 7.0X70MM Closed Head Multiaxial Screw | In distribution |
| 14-563365 | 4.75 CLOSED MAS closed MAS 5.5X65MM Closed Head Multiaxial Screw | In distribution |
| 14-585251CL | 4.5X510MM COCR LOW MR CRV ROD FOR MORE CURVED CONNECTOR | In distribution |
| 14-582937 | 4.75 TI 9.5X120MM MAS MULTIAXIAL SCREW | In distribution |
| 14-562061 | POL4.75 OPEN MAS 4.0X145MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-563945 | POL4.75 Closed MAS 9.5X45MM Closed Head Multiaxial Screw | In distribution |
| 14-587160T | 4.75X600MM TI ALLOY HEX ROD STRAIGHT | In distribution |
| 14-582560 | 4.75 TI 6.5X60MM MAS MULTIAXIAL SCREW | In distribution |
| 14-563165 | 4.75 CLOSED MAS closed MAS 4.5X65MM Closed Head Multiaxial Screw | In distribution |
| 14-583321 | 4.75 TI 5.5X105MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-562870 | POL4.75 Open MAS 8.5X70MM Multiaxial Screw | In distribution |
| 14-563920 | POL4.75 CLOSED MAS 9.5X20MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-589750 | 4.75 TI 50MM LAT CONN LATERAL CONNECTOR | In distribution |
| 14-563930 | POL4.75 Closed MAS 9.5X30MM Closed Head Multiaxial Screw | In distribution |
| 14-585103T | 4.5X30MM TI ALLOY HEX ROD STRAIGHT | In distribution |
| 14-563666 | POL4.75 CLOSED MAS 7.0X150MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-582725 | 4.75 TI 7.5X25MM MAS MULTIAXIAL SCREW | In distribution |
| 14-562185 | POL4.75 Open MAS 4.5X85MM Multiaxial Screw | In distribution |
| 14-584365 | 4.75 TI 5.5X65MM FIXED SCREW FIXED SCREW | In distribution |
| 14-584675 | 4.75 TI 7.0X75MM FIXED SCREW FIXED SCREW | In distribution |
| 14-582256 | 4.75 TI 5.0X140MM MAS MULTIAXIAL SCREW | In distribution |
| 14-563799 | POL4.75 CLOSED MAS 7.5X100MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-582899 | 4.75 TI 8.5X100MM MAS MULTIAXIAL SCREW | In distribution |
| 14-583485 | 4.75 TI 6.0X85MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-563675 | POL4.75 CLOSED MAS 7.0X75MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-583441 | 4.75 TI 6.0X125MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-562931 | POL4.75 OPEN MAS 10.5X30MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-581845 | 4.75 TI MEDIUM EXTENDED HOOK | In distribution |
| 14-563555 | 4.75 CLOSED MAS closed MAS 6.5X55MM Closed Head Multiaxial Screw | In distribution |
| 14-580921 | 4.75 TI LG UNIV CLOSING HOOK LARGE UNIVERSAL CLOSING HOOK | In distribution |
| 14-562930 | POL4.75 Open MAS 9.5X30MM Multiaxial Screw | In distribution |
| 14-563126 | 4.75 CLOSED MAS closed MAS 4.5X110MM Closed Head Multiaxial Screw | In distribution |
| 14-589108 | 4.75 TI 85MM STRGT AXIAL CONN STRAIGHT AXIAL CONNECTOR | In distribution |
| 14-583785 | 4.75 TI 7.5X85MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-563431 | 4.75 CLOSED MAS CLOSED MAS 6.0X115MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-584035 | 4.75 TI 4.0X35MM FIXED SCREW FIXED SCREW | In distribution |
| 14-584866 | 4.75 TI 8.5X150MM FIXED SCREW FIXED SCREW | In distribution |
| 14-562790 | POL4.75 OPEN MAS 7.5X90MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-580913N | 4.75TI 13.5MM UNIV HK NO SPIKE 13.5MM UNIVERSAL HOOK | In distribution |
| 14-582456 | 4.75 TI 6.0X140MM MAS MULTIAXIAL SCREW | In distribution |
| 14-582055 | 4.75 TI 4.0X55MM MAS MULTIAXIAL SCREW | In distribution |
| 14-562665 | POL4.75 OPEN MAS 7.0X65MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-562066 | POL4.75 Open MAS 4.0X150MM Multiaxial Screw | In distribution |
| 14-584928 | 4.75 TI 10.5X27.5MM FIXD SCREW FIXED SCREW | In distribution |
| 14-563466 | 4.75 CLOSED MAS closed MAS 6.0X150MM Closed Head Multiaxial Screw | In distribution |
| 14-582990 | 4.75 TI 9.5X90MM MAS MULTIAXIAL SCREW | In distribution |
| 14-563199 | 4.75 CLOSED MAS closed MAS 4.5X100MM Closed Head Multiaxial Screw | In distribution |
| 14-582051 | 4.75 TI 4.0X135MM MAS MULTIAXIAL SCREW | In distribution |
| 14-562955 | POL4.75 Open MAS 9.5X55MM Multiaxial Screw | In distribution |
| 14-584240 | 4.75 TI 5.0X40MM FIXED SCREW FIXED SCREW | In distribution |
| 14-562925 | POL4.75 Open MAS 9.5X25MM Multiaxial Screw | In distribution |
| 14-563166 | 4.75 CLOSED MAS closed MAS 4.5X150MM Closed Head Multiaxial Screw | In distribution |
| 14-562556 | POL4.75 Open MAS 6.5X140MM Multiaxial Screw | In distribution |
| 14-589310 | 4.75 TI 100MM LESS CRV AX CONN LESS CURVED AXIAL CONNECTOR | In distribution |
| 14-584245 | 4.75 TI 5.0X45MM FIXED SCREW FIXED SCREW | In distribution |
| 14-562960 | POL4.75 OPEN MAS 9.5X60MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-563375 | 4.75 CLOSED MAS CLOSED MAS 5.5X75MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-588560T | 4.75/5.5X600MM TI ALLOY ROD TRANSITION | In distribution |
| 14-582826 | 4.75 TI 8.5X110MM MAS MULTIAXIAL SCREW | In distribution |
| 14-582660 | 4.75 TI 7.0X60MM MAS MULTIAXIAL SCREW | In distribution |
| 14-562725 | POL4.75 Open MAS 7.5X25MM Multiaxial Screw | In distribution |
| 14-562125 | POLARIS 4.75 4.5MM X 25MM Multiaxial Screw | In distribution |
| 14-583099 | 4.75 TI 4.0X100MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-563965 | POL4.75 Closed MAS 9.5X65MM Closed Head Multiaxial Screw | In distribution |
| 14-582830 | 4.75 TI 8.5X30MM MAS MULTIAXIAL SCREW | In distribution |
| 14-584841 | 4.75 TI 8.5X125MM FIXED SCREW FIXED SCREW | In distribution |
| 14-563755 | POL4.75 CLOSED MAS 7.5X55MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-584661 | 4.75 TI 7.0X145MM FIXED SCREW FIXED SCREW | In distribution |
| 14-583870 | 4.75 TI 8.5X70MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-584530 | 4.75 TI 6.5X30MM FIXED SCREW FIXED SCREW | In distribution |
| 14-563435 | 4.75 CLOSED MAS CLOSED MAS 6.0X35MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-562060 | POL4.75 OPEN MAS 4.0X60MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-563475 | 4.75 CLOSED MAS CLOSED MAS 6.0X75MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-562621 | POL4.75 Open MAS 7.0X105MM Multiaxial Screw | In distribution |
| 14-563822 | POL4.75 Closed MAS 8.5X22.5MM Closed Head Multiaxial Screw | In distribution |
| 14-562899 | POL4.75 Open MAS 8.5X100MM Multiaxial Screw | In distribution |
| 14-582971 | 4.75 TI 10.5X70MM MAS MULTIAXIAL SCREW | In distribution |
| 14-584427 | 4.75 TI 6.0X27.5MM FIXED SCREW FIXED SCREW | In distribution |
| 14-582321 | 4.75 TI 5.5X105MM MAS MULTIAXIAL SCREW | In distribution |
| 14-583875 | 4.75 TI 8.5X75MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-583146 | 4.75 TI 4.5X130MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-584890 | 4.75 TI 8.5X90MM FIXED SCREW FIXED SCREW | In distribution |
| 14-563941 | POL4.75 Closed MAS 10.5X40MM Closed Head Multiaxial Screw | In distribution |
| 14-583627 | 4.75 TI 7.0X27.5MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-563830 | POL4.75 CLOSED MAS 8.5X30MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-582866 | 4.75 TI 8.5X150MM MAS MULTIAXIAL SCREW | In distribution |
| 14-584627 | 4.75 TI 7.0X27.5MM FIXED SCREW FIXED SCREW | In distribution |
| 14-582655 | 4.75 TI 7.0X55MM MAS MULTIAXIAL SCREW | In distribution |
| 14-563241 | 4.75 CLOSED MAS closed MAS 5.0X125MM Closed Head Multiaxial Screw | In distribution |
| 14-562990 | POL4.75 Open MAS 9.5X90MM Multiaxial Screw | In distribution |
| 14-584380 | 4.75 TI 5.5X80MM FIXED SCREW FIXED SCREW | In distribution |
| 14-562220 | POLARIS 4.75 5.0MM X 20MM Multiaxial Screw | In distribution |
| 14-584020 | 4.75 TI 4.0X20MM FIXED SCREW FIXED SCREW | In distribution |
| 14-589093 | 4.75 TI XS PELVIC SADDLE 5.5mm ROD | In distribution |
| 14-563727 | POL4.75 Closed MAS 7.5X27.5MM Closed Head Multiaxial Screw | In distribution |
| 14-584991 | 4.75 TI 10.5X90MM FIXED SCREW FIXED SCREW | In distribution |
| 14-562921 | POL4.75 Open MAS 10.5X20MM Multiaxial Screw | In distribution |
| 14-563626 | POL4.75 Closed MAS 7.0X110MM Closed Head Multiaxial Screw | In distribution |
| 14-584455 | 4.75 TI 6.0X55MM FIXED SCREW FIXED SCREW | In distribution |
| 14-563790 | POL4.75 CLOSED MAS 7.5X90MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-563775 | POL4.75 CLOSED MAS 7.5X75MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-581790 | 4.75 TI 9MM ANG BLADE HOOK ANGLED BLADE HOOK | In distribution |
| 14-563626 | POL4.75 CLOSED MAS 7.0X110MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-563525 | 4.75 CLOSED MAS CLOSED MAS 6.5X25MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-562141 | POL4.75 Open MAS 4.5X125MM Multiaxial Screw | In distribution |
| 14-584490 | 4.75 TI 6.0X90MM FIXED SCREW FIXED SCREW | In distribution |
| 14-562861 | POL4.75 OPEN MAS 8.5X145MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-583951 | 4.75 TI 10.5X50MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-563425 | 4.75 CLOSED MAS CLOSED MAS 6.0X25MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-582336 | 4.75 TI 5.5X120MM MAS MULTIAXIAL SCREW | In distribution |
| 14-584499 | 4.75 TI 6.0X100MM FIXED SCREW FIXED SCREW | In distribution |
| 14-581650L | 4.75 TI 5MM LEFT OFFSET HOOK | In distribution |
| 14-562627 | POL4.75 Open MAS 7.0X27.5MM Multiaxial Screw | In distribution |
| 14-562456 | POL4.75 Open MAS 6.0X140MM Multiaxial Screw | In distribution |
| 14-562465 | POL4.75 Open MAS 6.0X65MM Multiaxial Screw | In distribution |
| 14-563335 | 4.75 CLOSED MAS CLOSED MAS 5.5X35MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-584665 | 4.75 TI 7.0X65MM FIXED SCREW FIXED SCREW | In distribution |
| 14-583325 | 4.75 TI 5.5X25MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-583027 | 4.75 TI 4.0X27.5MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-583461 | 4.75 TI 6.0X145MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-583395 | 4.75 TI 5.5X95MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-583460 | 4.75 TI 6.0X60MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-581475 | 4.75 TI 7.5MM LAMINAR HOOK | In distribution |
| 14-582021 | 4.75 TI 4.0X105MM MAS MULTIAXIAL SCREW | In distribution |
| 14-582950 | 4.75 TI 9.5X50MM MAS MULTIAXIAL SCREW | In distribution |
| 14-584670 | 4.75 TI 7.0X70MM FIXED SCREW FIXED SCREW | In distribution |
| 14-563490 | 4.75 CLOSED MAS CLOSED MAS 6.0X90MM CLOSED HEAD MULTIAXIAL SCREW SINGLE LEAD | In distribution |
| 14-584420 | 4.75 TI 6.0X20MM FIXED SCREW FIXED SCREW | In distribution |
| 14-562475 | POL4.75 Open MAS 6.0X75MM Multiaxial Screw | In distribution |
| 14-563967 | POL4.75 Closed MAS 9.5X150MM Closed Head Multiaxial Screw | In distribution |
| 14-584140 | 4.75 TI 4.5X40MM FIXED SCREW FIXED SCREW | In distribution |
| 14-563625 | POL4.75 Closed MAS 7.0X25MM Closed Head Multiaxial Screw | In distribution |
| 14-585351CS | 4.5X510MM COCR STD LS CRV ROD FOR LESS CURVED CONNECTOR | In distribution |
| 14-563460 | 4.75 CLOSED MAS closed MAS 6.0X60MM Closed Head Multiaxial Screw | In distribution |
| 14-584720 | 4.75 TI 7.5X20MM FIXED SCREW FIXED SCREW | In distribution |
| 14-582440 | 4.75 TI 6.0X40MM MAS MULTIAXIAL SCREW | In distribution |
| 14-563521 | 4.75 CLOSED MAS closed MAS 6.5X105MM Closed Head Multiaxial Screw | In distribution |
| 14-583430 | 4.75 TI 6.0X30MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-584556 | 4.75 TI 6.5X140MM FIXED SCREW FIXED SCREW | In distribution |
| 14-582631 | 4.75 TI 7.0X115MM MAS MULTIAXIAL SCREW | In distribution |
| 14-581040 | 4.75 TI 4MM MIDSTEM HOOK | In distribution |
| 14-562180 | POL4.75 Open MAS 4.5X80MM Multiaxial Screw | In distribution |
| 14-581635R | 4.75 TI 3.5MM RT OFFSET HOOK RIGHT OFFSET HOOK | In distribution |
| 14-583530 | 4.75 TI 6.5X30MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-563341 | 4.75 CLOSED MAS closed MAS 5.5X125MM Closed Head Multiaxial Screw | In distribution |
| 14-562356 | POL4.75 Open MAS 5.5X140MM Multiaxial Screw | In distribution |
| 14-584780 | 4.75 TI 7.5X80MM FIXED SCREW FIXED SCREW | In distribution |
| 14-583956 | 4.75 TI 10.5X55MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-583125 | 4.75 TI 4.5X25MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-584940 | 4.75 TI 9.5X40MM FIXED SCREW FIXED SCREW | In distribution |
| 14-583399 | 4.75 TI 5.5X100MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-587360T | 4.75X600MM TI ALLOY LS CRV ROD FOR LESS CURVED CONNECTOR | In distribution |
| 14-587151CL | 4.75X510MM COCR LOW HEX ROD STRAIGHT | In distribution |
| 14-582565 | 4.75 TI 6.5X65MM MAS MULTIAXIAL SCREW | In distribution |
| 14-562199 | POL4.75 OPEN MAS 4.5X100MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-562325 | POLARIS 4.75 5.5MM X 25MM Multiaxial Screw | In distribution |
| 14-563041 | 4.75 CLOSED MAS closed MAS 4.0X125MM Closed Head Multiaxial Screw | In distribution |
| 14-582981 | 4.75 TI 10.5X80MM MAS MULTIAXIAL SCREW | In distribution |
| 14-585245CS | 4.5X450MM COCR STD MR CRV ROD FOR MORE CURVED CONNECTOR | In distribution |
| 14-562945 | POL4.75 OPEN MAS 9.5X45MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-582365 | 4.75 TI 5.5X65MM MAS MULTIAXIAL SCREW | In distribution |
| 14-582635 | 4.75 TI 7.0X35MM MAS MULTIAXIAL SCREW | In distribution |
| 14-563331 | 4.75 CLOSED MAS closed MAS 5.5X115MM Closed Head Multiaxial Screw | In distribution |
| 14-589524 | 4.75 TI 24MM FIXED CROSS CONN FIXED CROSS CONNECTOR | In distribution |
| 14-562045 | POLARIS 4.75 4.0MM X 45MM Multiaxial Screw | In distribution |
| 14-587130CH | 4.75X300MM COCR HIGH HEX ROD STRAIGHT | In distribution |
| 14-588551CH | 4.75/5.5X510MM COCR HIGH ROD TRANSITION | In distribution |
| 14-583445 | 4.75 TI 6.0X45MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-581240R | 4.75 TI 4MM RIGHT ANGLED HOOK | In distribution |
| 14-563565 | 4.75 CLOSED MAS closed MAS 6.5X65MM Closed Head Multiaxial Screw | In distribution |
| 14-582380 | 4.75 TI 5.5X80MM MAS MULTIAXIAL SCREW | In distribution |
| 14-587160CL | 4.75X600MM COCR LOW HEX ROD STRAIGHT | In distribution |
| 14-583499 | 4.75 TI 6.0X100MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-563485 | 4.75 CLOSED MAS closed MAS 6.0X85MM Closed Head Multiaxial Screw | In distribution |
| 14-581275R | 4.75 TI 7.5MM RT ANGLED HOOK RIGHT ANGLED HOOK | In distribution |
| 14-562155 | POL4.75 Open MAS 4.5X55MM Multiaxial Screw | In distribution |
| 14-562175 | POL4.75 OPEN MAS 4.5X75MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-584926 | 4.75 TI 10.5X25MM FIXED SCREW FIXED SCREW | In distribution |
| 14-582870 | 4.75 TI 8.5X70MM MAS MULTIAXIAL SCREW | In distribution |
| 14-562231 | POL4.75 OPEN MAS 5.0X115MM MULTIAXIAL SCREW POLARIS 4.75 TI SPINAL SYSTEM | In distribution |
| 14-586551CS | 4.5/5.5X510MM COCR STD ROD TRANSITION | In distribution |
| 14-583380 | 4.75 TI 5.5X80MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-562650 | POL4.75 Open MAS 7.0X50MM Multiaxial Screw | In distribution |
| 14-584830 | 4.75 TI 8.5X30MM FIXED SCREW FIXED SCREW | In distribution |
| 14-583365 | 4.75 TI 5.5X65MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-583241 | 4.75 TI 5.0X125MM CLOSED MAS CLOSED HEAD MULTIAXIAL SCREW | In distribution |
| 14-562331 | POL4.75 Open MAS 5.5X115MM Multiaxial Screw | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K103393 | 2011-02-02 |
| K080646 | 2008-05-02 |
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.