Polaris™ 5.5 Spinal System
877 catalogue numbers from 14-578350, 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
877catalogue 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 | 2020-07-07 |
| Record revised | 2025-07-02 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-578350 | 5.5 TI 5.5X50MM TRANSLATION TRANSLATION SCREW | In distribution |
| 2000-7750C | SCREW, 9.5MM X 50MM MULTIAXIAL CANNULATED REDUCTION | In distribution |
| 14-512440E | 6.5MM X 40MM UNIPLANAR SCREW | In distribution |
| 2000-7425C | SCREW, 6.5MM X 25MM MULTIAXIAL CANNULATED REDUCTION | In distribution |
| 94491 | 24MM FIXED CROSS CONNECTOR | In distribution |
| 2000-7620 | 8.5X20MM MULTIAXIAL RED.SCREW | In distribution |
| 14-500576 | 5.5MM DIA X 510MM LOW COCR ALLOY ROD | In distribution |
| 14-505126 | 75MM LATERAL CONNECTOR, OPEN 5.5 SST | In distribution |
| 2000-2540E | 7.5 X 40MM MULTIAXIAL SCREW | In distribution |
| 14-500317 | DIA 7.5MM X 95MM MULTIAXIAL ILIAC SCREW 5.5 | In distribution |
| 14-500273 | DIA 5.5MM X 75MM MULTIAXIAL ILIAC SCREW 5.5 | In distribution |
| 2000-7690C | SCREW, 8.5MM X 90MM MULTIAXIAL CANNULATED REDUCTION | In distribution |
| 14-510740 | 5.5 TI 7.5 X 40MM TAPERED MAS TAPERED MULTIAXIAL SCREW | In distribution |
| 14-500599 | 5.5MM DIA X 480MM HARD PREBENT COCR ALLOY ROD | In distribution |
| 2000-4555E | 7.5 X 55MM FIXED SCREW | In distribution |
| 14-503420 | 6.5 X 20MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-512599R | 7.5MM X 100MM REDUCTION | In distribution |
| 2000-7470 | 6.5X70MM MULTIAXIAL RED.SCREW | In distribution |
| 14-578450 | 5.5 TI 6.5X50MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-506350R | 5.5MM X 50MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-503755 | 9.5 X 55MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-500291 | DIA 6.5MM X 65MM MULTIAXIAL | In distribution |
| 2000-7670C | SCREW, 8.5MM X 70MM MULTIAXIAL | In distribution |
| 2000-7499C | SCREW,6.5MM X 100MM MULTIAXIAL CANNULATED REDUCTION | In distribution |
| 14-503450 | 6.5 X 50MM MULTIAXIAL ILIAC | In distribution |
| 14-512830R | 10.5MM X 30MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-500332E | 8.5 mm ø x 70 mm Multiaxial Iliac Screw | In distribution |
| 2000-7621 | 8.5MM X 20MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 14-504135 | 4.0MM X 35MM FIXED SCREW 5.5 SST | In distribution |
| 14-500332E | 8.5MM DIA X 70MM MULTIAXIAL | In distribution |
| 2000-4785 | 9.5 X 85MM FIXED SCREW | In distribution |
| 14-500600 | 5.5MM DIA X 510MM HARD PREBENT COCR ALLOY ROD | In distribution |
| 2000-2135 | 4.0MM DIA X 35MM STANDARD MULTIAXIAL SCREW | In distribution |
| 14-512465R | 6.5MM X 65MM REDUCTION | In distribution |
| 2000-4799 | 9.5 X 100MM FIXED SCREW | In distribution |
| 14-503165 | 4.0 X 65MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-504435 | 6.5MM X 35MM FIXED SCREW 5.5 SST | In distribution |
| 2000-2580 | 7.5X80MM MULTIAXIAL SCREW | In distribution |
| 14-500290E | 6.5 mm ø x 60 mm Multiaxial Iliac Screw | In distribution |
| 14-500304 | DIA 7.5MM X 30MM MULTIAXIAL ILIAC SCREW 5.5 | In distribution |
| 14-502545 | 7.5 X 45MM MULTIAXIAL SCREW 5.5 SST | In distribution |
| 2000-5413 | 120MM TI ALLOY CURVED ROD | In distribution |
| 14-506335R | 5.5MM X 35MM REDUCTION UNIPLANAR SCREW | In distribution |
| 2000-7550C | SCREW, 7.5MM X 50MM MULTIAXIAL | In distribution |
| 14-503345 | 5.5 X 45MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 2000-7325 | 5.5X25MM MULTIAXIAL RED.SCREW | In distribution |
| 2000-4530 | 7.5 X 30MM FIXED SCREW | In distribution |
| 2000-7455 | 6.5X55MM MULTIAXIAL RED.SCREW | In distribution |
| 14-504455 | 6.5MM X 55MM FIXED SCREW 5.5 SST | In distribution |
| 2000-4150 | 4.0MM DIA. X 50MM FIXED SCREW | In distribution |
| 2000-2170 | 4.0MM DIA X 70MM STANDARD | In distribution |
| 2000-2535 | 7.5X35MM MULTIAXIAL SCREW | In distribution |
| 2000-4785 | 9.5 X 85MM FIXED SCREW | In distribution |
| 14-504899 | 10.5MM X 100MM FIXED SCREW 5.5 SST | In distribution |
| 14-506875R | 10.5MM X 75MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-578610R | 5.5 TI 8.5X150MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-512740R | 9.5MM X 40MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-502635 | 8.5 X 35MM MULTIAXIAL SCREW 5.5 SST | In distribution |
| 14-512330RE | 5.5MM X 30MM REDUCTION | In distribution |
| 14-512235RE | 4.75 mm x 35 mm Reduction Uniplanar Screw | In distribution |
| 14-512240E | 4.75 mm x 40 mm Uniplanar Screw | In distribution |
| 14-504290 | 4.75MM X 90MM FIXED SCREW 5.5 | In distribution |
| 2000-5065 | 65MM CP TI CURVED ROD | In distribution |
| 2000-1022E | Lateral Connector, Open, 50 mm | In distribution |
| 14-500817E | 5.5 mm x 6.35 mm Parallel Ti Domino | In distribution |
| 14-504370 | 5.5MM X 70MM FIXED SCREW 5.5 SST | In distribution |
| 14-504490 | 6.5MM X 90MM FIXED SCREW 5.5 SST | In distribution |
| 14-504740 | 9.5MM X 40MM FIXED SCREW 5.5 | In distribution |
| 14-500616 | 5.5MM DIA X 470MM XX-HARD PREBENT COCR ALLOY ROD | In distribution |
| 2000-4430 | 6.5 X 30MM FIXED SCREW | In distribution |
| 2000-4440E | 6.5 x 40 mm Fixed Screw | In distribution |
| 2000-4240E | 4.75 x 40 mm Fixed Screw | In distribution |
| 2000-7465C | SCREW, 6.5MM X 65MM MULTIAXIAL CANNULATED REDUCTION | In distribution |
| 2000-4475 | 6.5 X 75MM FIXED SCREW | In distribution |
| 2000-4650E | 8.5 X 50MM FIXED SCREW | In distribution |
| 2000-7646 | 8.5MM X 45MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 14-504499 | 6.5MM X 100MM FIXED SCREW 5.5 SST | In distribution |
| 2000-7330C | SCREW 5.5MM X 30MM MULTIAXIAL | In distribution |
| 2000-2135E | 4.0 mm ø x 35 mm Standard Multiaxial Screw | In distribution |
| 14-512720R | 9.5MM X 20MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-512520R | 7.5MM X 20MM REDUCTION | In distribution |
| 14-578804 | 5.5 TI 10.5 X120MM TRANSLATION TRANSLATION SCREW | In distribution |
| 2000-2720 | 9.5X20MM MULTIAXIAL SCREW | In distribution |
| 2000-5514 | LEFT ANGLED HOOK, LARGE (9MM) | In distribution |
| 2000-5010 | 105MM CP TI CURVED ROD | In distribution |
| 2000-4855 | 10.5 X 55MM FIXED SCREW | In distribution |
| 2000-4860 | 10.5 X 60MM FIXED SCREW | In distribution |
| 2000-2445 | 6.5X45MM MULTIAXIAL SCREW | In distribution |
| 14-504740 | 9.5MM X 40MM FIXED SCREW 5.5 SST | In distribution |
| 14-504640 | 8.5MM X 40MM FIXED SCREW 5.5 | In distribution |
| 2000-5570 | RIGHT TRANSVERSE PROCESS HOOK, | In distribution |
| 2000-2640E | 8.5 X 40MM MULTIAXIAL SCREW | In distribution |
| 14-500130E | 12 mm Fixed Cross Connector | In distribution |
| 2000-2299 | 4.75X100MM MULTIAXIAL SCREW | In distribution |
| 2000-2545 | 7.5X45MM MULTIAXIAL SCREW | In distribution |
| 14-504790 | 9.5MM X 90MM FIXED SCREW 5.5 | In distribution |
| 14-578601R | 5.5 TI 8.5X105MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 2000-7796 | 9.5MM X 95MM REDUCTION SCREW | In distribution |
| 2000-5140 | 40MM TI ALLOY CURVED ROD | In distribution |
| 2000-5415 | 130MM TI ALLOY CURVED ROD | In distribution |
| 14-512685R | 8.5MM X 85MM REDUCTION | In distribution |
| 14-504430 | 6.5MM X 30MM FIXED SCREW 5.5 SST | In distribution |
| 2000-4320 | 5.5 X 20MM FIXED SCREW | In distribution |
| 14-503675 | 8.5 X 75MM MULTIAXIAL ILIAC | In distribution |
| 14-500592 | 5.5MM DIA X 610MM HIGH HEX COCR ALLOY ROD | In distribution |
| 14-504665 | 8.5MM X 65MM FIXED SCREW 5.5 SST | In distribution |
| 2000-4299 | 4.75 X 100MM FIXED SCREW | In distribution |
| 14-512480 | 6.5MM X 80MM UNIPLANAR SCREW | In distribution |
| 2000-4565 | 7.5 X 65MM FIXED SCREW | In distribution |
| 2000-7398 | 5.5MM X 100MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 14-512785R | 9.5MM X 85MM REDUCTION | In distribution |
| 14-504245 | 4.75MM X 45MM FIXED SCREW 5.5 SST | In distribution |
| 14-500293 | DIA 6.5MM X 75MM MULTIAXIAL | In distribution |
| 2000-5546E | RIGHT OFFSET HOOK, LARGE (9MM) | In distribution |
| 14-512330E | 5.5 mm x 30 mm Uniplanar Screw | In distribution |
| 14-503325 | 5.5 X 25MM MULTIAXIAL ILIAC | In distribution |
| 14-578660 | 5.5 TI 8.5X60MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-507455 | 6.5 X 55MM MULTIAXIAL REDUCTION SCREW, 5.5 SST | In distribution |
| 14-500284 | DIA 6.5MM X 30MM MULTIAXIAL ILIAC SCREW 5.5 | In distribution |
| 14-500270 | DIA 5.5MM X 60MM MULTIAXIAL ILIAC SCREW 5.5 | In distribution |
| 2000-5335 | 35MM CP TI CURVED ROD | In distribution |
| 2000-7599C | SCREW,7.5MM X 100MM MULTIAXIAL | In distribution |
| 2000-7866 | 10.5MM X 65MM REDUCTION SCREW | In distribution |
| 2000-2435E | 6.5 X 35MM MULTIAXIAL SCREW | In distribution |
| 14-510140 | 140MM 5.5 TI ALLOY ROD W/HEX | In distribution |
| 14-578307R | 5.5 TI 5.5X135MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 2000-4599 | 7.5 X 100MM FIXED SCREW | In distribution |
| 2000-4775 | 9.5 X 75MM FIXED SCREW | In distribution |
| 14-500370 | DIA 10.5MM X 60MM MULTIAXIAL ILIAC SCREW 5.5 | In distribution |
| 14-510540 | 5.5 TI 5.5 X 40MM TAPERED MAS TAPERED MULTIAXIAL SCREW | In distribution |
| 14-506499R | 6.5MM X 100MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-512430E | 6.5 mm x 30 mm Uniplanar Screw | In distribution |
| 2000-7540 | 7.5X40MM MULTIAXIAL RED.SCREW | In distribution |
| 14-504525 | 7.5MM X 25MM FIXED SCREW 5.5 | In distribution |
| 2000-2645E | 8.5 X 45MM MULTIAXIAL SCREW | In distribution |
| 2000-5311 | 110MM CP TI CURVED ROD | In distribution |
| 2000-4185 | 4.0MM DIA. X 85MM FIXED SCREW | In distribution |
| 2000-2870 | 10.5X70MM MULTIAXIAL SCREW | In distribution |
| 14-512620R | 8.5MM X 20MM REDUCTION UNIPLANAR SCREW | In distribution |
| 2000-4899 | 10.5 X 100MM FIXED SCREW | In distribution |
| 2000-2360 | 5.5X60MM MULTIAXIAL SCREW | In distribution |
| 14-500374 | DIA 10.5MM X 80MM MULTIAXIAL | In distribution |
| 2000-4185 | 4.0MM DIA. X 85MM FIXED SCREW | In distribution |
| 2000-7880C | SCREW,10.5MM X 80MM MULTIAXIAL | In distribution |
| 14-506885R | 10.5MM X 85MM REDUCTION UNIPLANAR SCREW | In distribution |
| 2000-5180 | 80MM TI ALLOY CURVED ROD | In distribution |
| 2000-4675 | 8.5 X 75MM FIXED SCREW | In distribution |
| 2000-7831 | 10.5MM X 30MM REDUCTION SCREW | In distribution |
| 2000-4650 | 8.5 X 50MM FIXED SCREW | In distribution |
| 14-504180 | 4.0MM X 80MM FIXED SCREW 5.5 SST | In distribution |
| 2000-7560C | SCREW, 7.5MM X 60MM MULTIAXIAL CANNULATED REDUCTION | In distribution |
| 2000-2775 | 9.5X75MM MULTIAXIAL SCREW | In distribution |
| 14-578602 | 5.5 TI 8.5X110MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-512630 | 8.5MM X 30MM UNIPLANAR SCREW | In distribution |
| 2000-2125E | 4.0 mm ø x 25 mm Standard Multiaxial Screw | In distribution |
| 2000-4199 | 4.0MM DIA. X 100MM FIXED SCREW | In distribution |
| 2000-2645 | 8.5X45MM MULTIAXIAL SCREW | In distribution |
| 2000-4195 | 4.0MM DIA. X 95MM FIXED SCREW | In distribution |
| 2000-2560 | 7.5X60MM MULTIAXIAL SCREW | In distribution |
| 2000-4165 | 4.0MM DIA. X 65MM FIXED SCREW | In distribution |
| 14-512550E | 7.5MM X 50MM UNIPLANAR SCREW | In distribution |
| 14-512645R | 8.5MM X 45MM REDUCTION UNIPLANAR SCREW | In distribution |
| 2000-7546 | 7.5MM X 45MM REDUCTION SCREW | In distribution |
| 14-578370 | 5.5 TI 5.5X70MM TRANSLATION TRANSLATION SCREW | In distribution |
| 2000-4630 | 8.5 X 30MM FIXED SCREW | In distribution |
| 2000-7256 | 4.75MM X 55MM REDUCTION SCREW | In distribution |
| 2000-2530E | 7.5 X 30MM MULTIAXIAL SCREW | In distribution |
| 2000-4860 | 10.5 X 60MM FIXED SCREW | In distribution |
| 2000-5410 | 105MM TI ALLOY CURVED ROD | In distribution |
| 2000-1008E | DEROTATION PLUG – 5.5 | In distribution |
| 14-503450 | 6.5 X 50MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-578302R | 5.5 TI 5.5X110MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 2000-2585 | 7.5X85MM MULTIAXIAL SCREW | In distribution |
| 14-578685 | 5.5 TI 8.5X85MM TRANSLATION TRANSLATION SCREW | In distribution |
| 2000-5534E | Narrow Reduced Laminar Hook, Large (9 mm) | In distribution |
| 14-503190 | 4.0 X 90MM MULTIAXIAL ILIAC | In distribution |
| 2000-2655E | 8.5 x 55 mm Multiaxial Screw | In distribution |
| 14-503850 | 10.5 X 50MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-506250R | 4.75MM X 50MM REDUCTION UNIPLANAR SCREW | In distribution |
| 2000-7645 | 8.5X45MM MULTIAXIAL RED.SCREW | In distribution |
| 14-578209 | 5.5 TI 4.75X145MM TRANSLATION TRANSLATION SCREW | In distribution |
| 2000-4645E | 8.5 X 45MM FIXED SCREW | In distribution |
| 2000-2799 | 9.5X100MM MULTIAXIAL SCREW | In distribution |
| 14-503235 | 4.75 X 35MM MULTIAXIAL ILIAC | In distribution |
| 2000-7586 | 7.5MM X 85MM REDUCTION SCREW | In distribution |
| 2000-2890 | 10.5X90MM MULTIAXIAL SCREW | In distribution |
| 2000-7576 | 7.5MM X 75MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 2000-2850 | 10.5X50MM MULTIAXIAL SCREW | In distribution |
| 14-510650 | 5.5 TI 6.5 X 50MM TAPERED MAS TAPERED MULTIAXIAL SCREW | In distribution |
| 14-500353 | DIA 9.5MM X 75MM MULTIAXIAL | In distribution |
| 2000-7491 | 6.5MM X 90MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 2000-4245E | 4.75 X 45MM FIXED SCREW | In distribution |
| 2000-5160E | 60 mm Ti Alloy Curved Rod | In distribution |
| 14-504535 | 7.5MM X 35MM FIXED SCREW 5.5 SST | In distribution |
| 14-500338 | DIA 8.5MM X 100MM MULTIAXIAL | In distribution |
| 2000-5111 | 110MM TI ALLOY CURVED ROD | In distribution |
| 14-512685R | 8.5MM X 85MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-500590E | 300MM HIGH COCRMO ROD | In distribution |
| 2000-4145 | 4.0MM DIA. X 45MM FIXED SCREW | In distribution |
| 2000-7340C | SCREW, 5.5MM X 40MM MULTIAXIAL CANNULATED REDUCTION | In distribution |
| 2000-2650E | 8.5 x 50 mm Multiaxial Screw | In distribution |
| 14-512299R | 4.75MM X 100MM REDUCTION | In distribution |
| 14-505504 | PEDICLE HOOK- 5.5 SST (LARGE) | In distribution |
| 14-503345 | 5.5 X 45MM MULTIAXIAL ILIAC | In distribution |
| 2000-7840C | SCREW,10.5MM X 40MM MULTIAXIAL | In distribution |
| 14-503260 | 4.75 X 60MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 2000-5160 | 60MM TI ALLOY CURVED ROD | In distribution |
| 2000-7550E | 7.5 x 50 mm Multiaxial Red.Screw | In distribution |
| 2000-1024 | LATERAL CONNECTOR, OPEN, 75MM | In distribution |
| 14-504870 | 10.5MM X 70MM FIXED SCREW 5.5 SST | In distribution |
| 14-503335 | 5.5 X 35MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-504390 | 5.5MM X 90MM FIXED SCREW 5.5 | In distribution |
| 2000-7820C | SCREW,10.5MM X 20MM MULTIAXIAL | In distribution |
| 2000-4845 | 10.5 X 45MM FIXED SCREW | In distribution |
| 2000-5055 | 55MM CP TI CURVED ROD | In distribution |
| 14-500278 | DIA 5.5MM X 100MM MULTIAXIAL ILIAC SCREW 5.5 | In distribution |
| 14-512290R | 4.75MM X 90MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-512765 | 9.5MM X 65MM UNIPLANAR SCREW | In distribution |
| 5006760E | 16 mm Fixed Cross Connector | In distribution |
| 2000-7440C | SCREW, 6.5MM X 40MM MULTIAXIAL | In distribution |
| 14-512280R | 4.75MM X 80MM REDUCTION | In distribution |
| 14-505558 | EXTENDED LAMINAR HOOK 5.5 SST LARGE | In distribution |
| 14-578570R | 5.5 TI 7.5X70MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-510100 | 100MM 5.5 TI ALLOY ROD W/HEX | In distribution |
| 14-578404R | 5.5 TI 6.5X120MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-506365R | 5.5MM X 65MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-512845R | 10.5MM X 45MM REDUCTION | In distribution |
| 14-503750 | 9.5 X 50MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 2000-7766 | 9.5MM X 65MM REDUCTION SCREW | In distribution |
| 14-512320R | 5.5MM X 20MM REDUCTION | In distribution |
| 2000-7851 | 10.5MM X 50MM REDUCTION SCREW | In distribution |
| 14-578690 | 5.5 TI 8.5X90MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-504440 | 6.5MM X 40MM FIXED SCREW 5.5 | In distribution |
| 14-503225 | 4.75 X 25MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-504855 | 10.5MM X 55MM FIXED SCREW 5.5 SST | In distribution |
| 14-505409 | 610MM ROD, EXTRA HARD, SST 5.5MM DIA | In distribution |
| 14-512230RE | 4.75MM X 30MM REDUCTION | In distribution |
| 14-500585E | 510MM STANDARD COCRMO ROD | In distribution |
| 2000-7236 | 4.75MM X 35MM REDUCTION SCREW | In distribution |
| 2000-4835 | 10.5 X 35MM FIXED SCREW | In distribution |
| 2000-4740 | 9.5 X 40MM FIXED SCREW | In distribution |
| 2000-7771 | 9.5MM X 70MM REDUCTION SCREW | In distribution |
| 2000-7676 | 8.5MM X 75MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 2000-7335C | SCREW, 5.5MM X 35MM MULTIAXIAL CANNULATED REDUCTION | In distribution |
| 14-500295 | DIA 6.5MM X 85MM MULTIAXIAL | In distribution |
| 14-512545R | 7.5MM X 45MM REDUCTION | In distribution |
| 14-578206R | 5.5 TI 4.75X130MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 2000-2125E | 4.0MM DIA. X 25MM STANDARD | In distribution |
| 2000-2130 | 4.0MM DIA X 30MM STANDARD | In distribution |
| 2000-4660 | 8.5 X 60MM FIXED 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 |
| CastleLoc-P Anterior Cervical Plate System | L&K Biomed Co., Ltd. | 873 |
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.