Polaris 6.35 Spinal System
280 catalogue numbers from 53-6116MP, 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
280catalogue 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 | 2015-10-24 |
| Record revised | 2025-07-02 (version 7) |
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 |
|---|---|---|
| 53-6116MP | 7.0MM (D) X 35MM (L) EXTENDED | In distribution |
| 14-513650 | 8.5MM X 50MM UNIPLANAR SCREW | In distribution |
| 14-573690 | 8.5 X 90MM MULTIAXIAL ILIAC SCREW | In distribution |
| 50-6113MP | MULTI-AXIAL SCREW 6.5MM (D) X 45MM (L) | In distribution |
| 50-6116MP | MULTI-AXIAL SCREW 7.0MM (D) X 35MM (L) | In distribution |
| 14-573225 | 4.75 X 25MM MULTIAXIAL ILIAC | In distribution |
| 14-501062 | 26MM OUTSIDE FIXED CROSS 6.35 | In distribution |
| 14-573780 | 9.5 X 80MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 53-6106MP | 5.5MM (D) X 35MM (L) EXTENDED | In distribution |
| 53-6552MP | 4.0X30MM REDUCTION SEAT ASSY | In distribution |
| 14-574650 | 8.5MM(D) X 50MM FIXED SCREW | In distribution |
| 53-6108MP | 5.5MM (D) X 45MM (L) EXTENDED | In distribution |
| 14-501052 | 18MM MIXED FIXED CROSS 6.35 | In distribution |
| 14-513655 | 8.5MM X 55MM UNIPLANAR SCREW | In distribution |
| 14-513745 | 9.5MM X 45MM UNIPLANAR SCREW | In distribution |
| 14-573485 | 6.5 X 85MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 50-6109MP | 5.5MM (D) X 50MM (L) | In distribution |
| 14-572530 | 7.5 X 30MM MULTIAXIAL SCREW | In distribution |
| 14-513880R | 10.5MM X 80MM REDUCTION UNIPLANAR SCREW | In distribution |
| 53-6550MP | TI VARIABLE LOCKING SCREW 4.0x20MM REDUCTION SEAT ASSY | In distribution |
| 14-513650R | 8.5MM X 50MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-513280R | 4.75MM X 80MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-574445C | 6.5MM(D) X 45MM SST CANNULATED FIXED SCREW | In distribution |
| 50-6110MP | MULTI-AXIAL SCREW 6.5MM (D) X 30MM (L) | In distribution |
| 14-513275R | 4.75MM X 75MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-513670 | 8.5MM X 70MM UNIPLANAR SCREW | In distribution |
| 14-573675 | 8.5 X 75MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-513785R | 9.5MM X 85MM REDUCTION UNIPLANAR SCREW | In distribution |
| 50-6801MP | 7.0MM (D) X 55MM (L) | In distribution |
| 14-573860 | 10.5 X 60MM MULTIAXIAL ILIAC | In distribution |
| 14-513390 | 5.5MM X 90MM UNIPLANAR SCREW | In distribution |
| 14-513580R | 7.5MM X 80MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-573245 | 4.75 X 45MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 53-6105MP | 5.5MM (D) X 30MM (L) EXTENDED | In distribution |
| 50-6119MP | 7.0MM (D) X 50MM (L) | In distribution |
| 50-6117MP | MULTI-AXIAL SCREW 7.0MM (D) X 40MM (L) | In distribution |
| 14-513120 | 4.0MM X 20MM UNIPLANAR SCREW | In distribution |
| 14-501056 | 26MM MIXED FIXED CROSS 6.35 | In distribution |
| 14-574540 | 7.5MM(D) X 40MM FIXED SCREW | In distribution |
| 14-572345C | 5.5MM(D) X 45MM SST CANNULATED MULTI-AXIAL SCREW | In distribution |
| 14-575536 | SMALL: LEFT OFFSET HOOK | In distribution |
| 50-6117MP | 7.0MM (D) X 40MM (L) | In distribution |
| 53-6111MP | 6.5MM (D) X 35MM (L) EXTENDED | In distribution |
| 14-573899 | 10.5 X 100MM MULTIAXIAL ILIAC | In distribution |
| 14-513460R | 6.5MM X 60MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-501050 | 32MM INSIDE FIXED CROSS 6.35 | In distribution |
| 14-574350C | 5.5MM(D) X 50MM SST CANNULATED FIXED SCREW | In distribution |
| 14-573660 | 8.5 X 60MM MULTIAXIAL ILIAC SCREW | In distribution |
| 14-513445 | 6.5MM X 45MM UNIPLANAR SCREW | In distribution |
| 14-515420 | 6.35 TI 6.5X20MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 53-6113MP | 6.5MM (D) X 45MM (L) EXTENDED | In distribution |
| 53-6109MP | REDUCTION MULTI-AXIAL SCREW 5.5MM (D) X 50MM (L) EXTENDED | In distribution |
| 50-6118MP | MULTI-AXIAL SCREW 7.0MM (D) X 45MM (L) | In distribution |
| 14-515580 | 6.35 TI 7.5X80MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 53-6108MP | REDUCTION MULTI-AXIAL SCREW 5.5MM (D) X 45MM (L) EXTENDED | In distribution |
| 14-513230R | 4.75MM X 30MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-573190 | 4.0 X 90MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-501060 | 22MM OUTSIDE FIXED CROSS 6.35 | In distribution |
| 53-6550MP | 4.0X20MM REDUCTION SEAT ASSY | In distribution |
| 53-6117MP | 7.0MM (D) X 40MM (L) EXTENDED | In distribution |
| 14-573725 | 9.5 X 25MM MULTIAXIAL ILIAC | In distribution |
| 14-573440 | 6.5 X 40MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-513280 | 4.75MM X 80MM UNIPLANAR SCREW | In distribution |
| 14-573365 | 5.5 X 65MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-572630C | 8.5MM(D) X 30MM SST CANNULATED MULTI-AXIAL SCREW | In distribution |
| 14-515899 | 6.35 TI 10.5X100MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-501049 | 30MM INSIDE FIXED CROSS 6.35 | In distribution |
| 14-501048 | 28MM INSIDE FIXED CROSS 6.35 | In distribution |
| 53-6110MP | 6.5MM (D) X 30MM (L) EXTENDED | In distribution |
| 14-574450C | 6.5MM(D) X 50MM SST CANNULATED FIXED SCREW | In distribution |
| 14-513880 | 10.5MM X 80MM UNIPLANAR SCREW | In distribution |
| 14-513260 | 4.75MM X 60MM UNIPLANAR SCREW | In distribution |
| 14-501055 | 24MM MIXED FIXED CROSS 6.35 | In distribution |
| 14-573595 | 7.5 X 95MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-513180 | 4.0MM X 80MM UNIPLANAR SCREW | In distribution |
| 14-513160R | 4.0MM X 60MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-577435 | 6.5MM(D) X 35MM SST MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-513790R | 9.5MM X 90MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-501053 | 20MM MIXED FIXED CROSS 6.35 | In distribution |
| 14-573430 | 6.5 X 30MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-573575 | 7.5 X 75MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-575560 | SMALL LEFT TP HOOK 6.35 SST | In distribution |
| 14-513265R | 4.75MM X 65MM REDUCTION UNIPLANAR SCREW | In distribution |
| 53-6107MP | REDUCTION MULTI-AXIAL SCREW 5.5MM (D) X 40MM (L) EXTENDED | In distribution |
| 14-575564 | MEDIUM LEFT TP HOOK 6.35 SST | In distribution |
| 53-6112MP | 6.5MM (D) X 40MM (L) EXTENDED | In distribution |
| 14-574645 | 8.5MM(D) X 45MM FIXED SCREW | In distribution |
| 53-6803MP | TI VARIABLE LOCKING SCREW 4.75 X 20MM REDUCT. SEAT ASSY | In distribution |
| 14-575512 | MEDIUM: RIGHT ANGLED HOOK | In distribution |
| 14-573775 | 9.5 X 75MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-513495R | 6.5MM X 95MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-513575R | 7.5MM X 75MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-515799 | 6.35 TI 9.5X100MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-513335R | 5.5MM X 35MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-573625 | 8.5 X 25MM MULTIAXIAL ILIAC | In distribution |
| 53-6112MP | REDUCTION MULTI-AXIAL SCREW 6.5MM (D) X 40MM (L) EXTENDED | In distribution |
| 14-572355C | 5.5MM(D) X 55MM SST CANNULATED MULTI-AXIAL SCREW | In distribution |
| 53-6119MP | 7.0MM (D) X 50MM (L) EXTENDED | In distribution |
| 53-6805MP | 4.75 X 30MM REDUCT. SEAT ASSY | In distribution |
| 14-515245 | 6.35 TI 4.75X45MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-513630R | 8.5MM X 30MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-513499R | 6.5MM X 100MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-513370R | 5.5MM X 70MM REDUCTION UNIPLANAR SCREW | In distribution |
| 53-6114MP | REDUCTION MULTI-AXIAL SCREW 6.5MM (D) X 50MM (L) EXTENDED | In distribution |
| 14-572450C | 6.5MM(D) X 50MM SST CANNULATED MULTI-AXIAL SCREW | In distribution |
| 14-574640 | 8.5MM(D) X 40MM FIXED SCREW | In distribution |
| 50-6110MP | 6.5MM (D) X 30MM (L) | In distribution |
| 53-6551MP | TI VARIABLE LOCKING SCREW 4.0x25MM REDUCTION SEAT ASSY | In distribution |
| 14-515525 | 6.35 TI 7.5X25MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-575407 | 610MM ROD, HARD, W/HEX, SST | In distribution |
| 50-6801MP | MULTI-AXIAL SCREW 7.0MM (D) X 55MM (L) | In distribution |
| 50-6115MP | MULTI-AXIAL SCREW 7.0MM (D) X 30MM (L) | In distribution |
| 14-513199R | 4.0MM X 100MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-513850 | 10.5MM X 50MM UNIPLANAR SCREW | In distribution |
| 14-573599 | 7.5 X 100MM MULTIAXIAL ILIAC | In distribution |
| 14-577430 | 6.5MM(D) X 30MM SST MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-513195R | 4.0MM X 90MM REDUCTION UNIPLANAR SCREW | In distribution |
| 50-6592MP | TI VARIABLE LOCKING SCREW 5.0 X 30MM HF SEAT ASSY | In distribution |
| 14-501048 | 28MM INSIDE FIXED CROSS 6.35 | In distribution |
| 53-6118MP | 7.0MM (D) X 45MM (L) EXTENDED | In distribution |
| 14-515760 | 6.35 TI 9.5X60MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 50-6105MP | MULTI-AXIAL SCREW 5.5MM (D) X 30MM (L) | In distribution |
| 14-501297 | 6.5MM(D) X 95MM(L) MULTIAXIAL | In distribution |
| 14-513399R | 5.5MM X 100MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-513585 | 7.5MM X 85MM UNIPLANAR SCREW | In distribution |
| 53-6116MP | REDUCTION MULTI-AXIAL SCREW 7.0MM (D) X 35MM (L) EXTENDED | In distribution |
| 50-6119MP | MULTI-AXIAL SCREW 7.0MM (D) X 50MM (L) | In distribution |
| 14-575570 | LARGE RIGHT TP HOOK 6.35 SST | In distribution |
| 14-574455 | 6.5MM(D) X 55MM FIXED SCREW | In distribution |
| 14-515720 | 6.35 TI 9.5X20MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-511640 | 8.5MM X 40MM MULTI-AXIAL SCREW | In distribution |
| 14-573675 | 8.5 X 75MM MULTIAXIAL ILIAC | In distribution |
| 14-573475 | 6.5 X 75MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-573335 | 5.5 X 35MM MULTIAXIAL ILIAC | In distribution |
| 14-573435 | 6.5 X 35MM MULTIAXIAL ILIAC | In distribution |
| 14-515840 | 6.35 TI 10.5X40MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-575566 | MEDIUM RIGHT TP HOOK 6.35 SST | In distribution |
| 53-6804MP | TI VARIABLE LOCKING SCREW 4.75 X 25MM REDUCT. SEAT ASSY | In distribution |
| 53-6806MP | 4.75 X 35MM REDUCT. SEAT ASSY | In distribution |
| 14-513870 | 10.5MM X 70MM UNIPLANAR SCREW | In distribution |
| 14-515645 | 6.35 TI 8.5X45MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-575168 | ANGULATING CROSS CONNECTOR,XXS | In distribution |
| 14-573620 | 8.5 X 20MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-573740 | 9.5 X 40MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 50-6111MP | 6.5MM (D) X 35MM (L) | In distribution |
| 50-6800MP | 6.5MM (D) X 55MM (L) | In distribution |
| 14-515350 | 6.35 TI 5.5X50MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-573275 | 4.75 X 75MM MULTIAXIAL ILIAC | In distribution |
| 53-6807MP | 4.75MM X 40MM(L) EXTENDED | In distribution |
| 14-511630 | 8.5MM X 30MM MULTI-AXIAL SCREW | In distribution |
| 14-574530 | 7.5MM(D) X 30MM FIXED SCREW | In distribution |
| 53-6115MP | 7.0MM (D) X 30MM (L) EXTENDED | In distribution |
| 14-573330 | 5.5 X 30MM MULTIAXIAL ILIAC | In distribution |
| 50-6106MP | 5.5MM (D) X 35MM (L) | In distribution |
| 53-6106MP | REDUCTION MULTI-AXIAL SCREW 5.5MM (D) X 35MM (L) EXTENDED | In distribution |
| 14-573745 | 9.5 X 45MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 50-6118MP | 7.0MM (D) X 45MM (L) | In distribution |
| 14-513535 | 7.5MM X 35MM UNIPLANAR SCREW | In distribution |
| 14-515885 | 6.35 TI 10.5X85MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 50-6112MP | MULTI-AXIAL SCREW 6.5MM (D) X 40MM (L) | In distribution |
| 14-574630C | 8.5MM(D) X 30MM SST CANNULATED FIXED SCREW | In distribution |
| 14-513245R | 4.75MM X 45MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-575405 | 610MM ROD, HARD, 6.35 SST | In distribution |
| 14-511545 | 7.5MM X 45MM MULTI-AXIAL SCREW | In distribution |
| 53-6115MP | REDUCTION MULTI-AXIAL SCREW 7.0MM (D) X 30MM (L) EXTENDED | In distribution |
| 50-6108MP | 5.5MM (D) X 45MM (L) | In distribution |
| 14-515530 | 6.35 TI 7.5X30MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-575534 | LARGE: NARROW REDUCED LAMINAR HOOK | In distribution |
| 14-573380 | 5.5 X 80MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-513820 | 10.5MM X 20MM UNIPLANAR SCREW | In distribution |
| 14-501061 | 24MM OUTSIDE FIXED CROSS 6.35 | In distribution |
| 53-6114MP | 6.5MM (D) X 50MM (L) EXTENDED | In distribution |
| 14-574335 | 5.5MM(D) X 35MM FIXED SCREW | In distribution |
| 14-515440 | 6.35 TI 6.5X40MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-513575 | 7.5MM X 75MM UNIPLANAR SCREW | In distribution |
| 14-515499 | 6.35 TI 6.5X100MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-513150R | 4.0MM X 50MM REDUCTION UNIPLANAR SCREW | In distribution |
| 53-6109MP | 5.5MM (D) X 50MM (L) EXTENDED | In distribution |
| 14-513690 | 8.5MM X 90MM UNIPLANAR SCREW | In distribution |
| 14-515375 | 6.35 TI 5.5X75MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-513330 | 5.5MM X 30MM UNIPLANAR SCREW | In distribution |
| 14-501049 | 30MM INSIDE FIXED CROSS 6.35 | In distribution |
| 14-513390R | 5.5MM X 90MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-513720R | 9.5MM X 20MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-511550 | 7.5MM X 50MM MULTI-AXIAL SCREW | In distribution |
| 14-573399 | 5.5 X 100MM MULTIAXIAL ILIAC | In distribution |
| 14-573795 | 9.5 X 95MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 53-6111MP | REDUCTION MULTI-AXIAL SCREW 6.5MM (D) X 35MM (L) EXTENDED | In distribution |
| 14-573160 | 4.0 X 60MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 50-6105MP | 5.5MM (D) X 30MM (L) | In distribution |
| 14-501050 | 32MM INSIDE FIXED CROSS 6.35 | In distribution |
| 50-6116MP | 7.0MM (D) X 35MM (L) | In distribution |
| 14-501060 | 22MM OUTSIDE FIXED CROSS 6.35 | In distribution |
| 14-575400 | 510MM ROD, MEDIUM, 6.35 SST | In distribution |
| 53-6803MP | 4.75 X 20MM REDUCT. SEAT ASSY | In distribution |
| 14-513175 | 4.0MM X 75MM UNIPLANAR SCREW | In distribution |
| 14-573720 | 9.5 X 20MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-573395 | 5.5 X 95MM MULTIAXIAL ILIAC | In distribution |
| 14-515235 | 6.35 TI 4.75X35MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-573225 | 4.75 X 25MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-513590 | 7.5MM X 90MM UNIPLANAR SCREW | In distribution |
| 14-573290 | 4.75 X 90MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-573490 | 6.5 X 90MM MULTIAXIAL ILIAC SCREW | In distribution |
| 14-573250 | 4.75 X 50MM MULTIAXIAL ILIAC | In distribution |
| 14-511530 | 7.5MM X 30MM MULTI-AXIAL SCREW | In distribution |
| 14-573345 | 5.5 X 45MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-513830R | 10.5MM X 30MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-513555 | 7.5MM X 55MM UNIPLANAR SCREW | In distribution |
| 14-573685 | 8.5 X 85MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 50-6114MP | MULTI-AXIAL SCREW 6.5MM (D) X 50MM (L) | In distribution |
| 14-501041 | 14MM INSIDE FIXED CROSS 6.35 | In distribution |
| 14-577345 | 5.5MM(D) X 45MM SST MULTIAXIAL REDUCTION SCREW | In distribution |
| 53-6113MP | REDUCTION MULTI-AXIAL SCREW 6.5MM (D) X 45MM (L) EXTENDED | In distribution |
| 50-6107MP | 5.5MM (D) X 40MM (L) | In distribution |
| 14-515220 | 6.35 TI 4.75X20MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-513435R | 6.5MM X 35MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-573260 | 4.75 X 60MM MULTIAXIAL ILIAC | In distribution |
| 14-573520 | 7.5 X 20MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-513450R | 6.5MM X 50MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-572445 | 6.5 X 45MM MULTIAXIAL SCREW | In distribution |
| 50-6112MP | 6.5MM (D) X 40MM (L) | In distribution |
| 14-513150 | 4.0MM X 50MM UNIPLANAR SCREW | In distribution |
| 50-6107MP | MULTI-AXIAL SCREW 5.5MM (D) X 40MM (L) | In distribution |
| 14-501298 | 6.5MM(D) X 100MM(L) MULTIAXIAL ILIAC SCREW (6.35) | In distribution |
| 14-573760 | 9.5 X 60MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-513655R | 8.5MM X 55MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-513675R | 8.5MM X 75MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-513145 | 4.0MM X 45MM UNIPLANAR SCREW | In distribution |
| 14-513865 | 10.5MM X 65MM UNIPLANAR SCREW | In distribution |
| 6587MP | VLS SCREW W/FLUTES-6.35 | In distribution |
| 14-573825 | 10.5 X 25MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 50-6800MP | MULTI-AXIAL SCREW 6.5MM (D) X 55MM (L) | In distribution |
| 50-6115MP | 7.0MM (D) X 30MM (L) | In distribution |
| 14-575415 | 280MM SST HARD ROD W/HEX | In distribution |
| 14-573135 | 4.0 X 35MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 53-6117MP | REDUCTION MULTI-AXIAL SCREW 7.0MM (D) X 40MM (L) EXTENDED | In distribution |
| 14-575413 | 280MM SST MEDIUM ROD W/HEX | In distribution |
| 50-6106MP | MULTI-AXIAL SCREW 5.5MM (D) X 35MM (L) | In distribution |
| 53-6107MP | 5.5MM (D) X 40MM (L) EXTENDED | In distribution |
| 14-513775R | 9.5MM X 75MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-513780R | 9.5MM X 80MM REDUCTIO UNIPLANAR SCREW | In distribution |
| 14-515785 | 6.35 TI 9.5X85MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-515780 | 6.35 TI 9.5X80MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-513855 | 10.5MM X 55MM UNIPLANAR SCREW | In distribution |
| 14-515380 | 6.35 TI 5.5X80MM MAS REDUC MULTIAXIAL REDUCTION SCREW | In distribution |
| 14-573755 | 9.5 X 55MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-575416 | 280MM ROD, EXTRA HARD, 6.35 SST | In distribution |
| 53-6110MP | REDUCTION MUTLI-AXIAL SCREW 6.5MM (D) X 30MM (L) EXTENDED | In distribution |
| 50-6114MP | 6.5MM (D) X 50MM (L) | In distribution |
| 53-6800MP | 6.5MM (D) X 55MM (L) EXTENDED | In distribution |
Showing 250 of 280 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.