Polaris™ 5.5 Spinal System
779 catalogue numbers from 14-506865R, listed by Biomet Spine, United States, under Thoracolumbosacral Pedicle Screw System. 15 manufacturers in China are registered for this product code.
15manufacturers in China registered for this device type
779catalogue numbers in this listing
5510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| 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 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Record published | 2020-06-24 |
| Record revised | 2025-07-02 (version 6) |
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 |
|---|---|---|
| 14-506865R | 10.5MM X 65MM REDUCTION UNIPLANAR SCREW | In distribution |
| 2000-7420 | 6.5X20MM MULTIAXIAL RED.SCREW | In distribution |
| 2000-7571 | 7.5MM X 70MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 2000-7485C | SCREW, 6.5MM X 85MM MULTIAXIAL CANNULATED REDUCTION | In distribution |
| 14-503445 | 6.5 X 45MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 2000-2635E | 8.5 X 35MM MULTIAXIAL SCREW | In distribution |
| 2000-7795 | 9.5X95MM MULTIAXIAL RED.SCREW | In distribution |
| 2000-5006 | 610MM CP TI ROD | In distribution |
| 2000-7530C | SCREW, 7.5MM X 30MM MULTIAXIAL CANNULATED REDUCTION | In distribution |
| 2000-7675C | SCREW, 8.5MM X 75MM MULTIAXIAL CANNULATED REDUCTION | In distribution |
| 2000-7666 | 8.5MM X 65MM REDUCTION SCREW | In distribution |
| 14-512430RE | 6.5 mm x 30 mm Reduction Uniplanar Screw | In distribution |
| 2000-4445E | 6.5 X 45MM FIXED SCREW | In distribution |
| 14-512350R | 5.5MM X 50MM REDUCTION UNIPLANAR SCREW | In distribution |
| 2000-4370 | 5.5 X 70MM FIXED SCREW | In distribution |
| 14-500244 | DIA 4.75MM X 30MM MULTIAXIAL | In distribution |
| 14-503835 | 10.5 X 35MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-512450R | 6.5MM X 50MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-504570 | 7.5MM X 70MM FIXED SCREW 5.5 SST | In distribution |
| 14-504420 | 6.5MM X 20MM FIXED SCREW 5.5 | In distribution |
| 14-500292E | 6.5MM DIA X 70MM MULTIAXIAL | In distribution |
| 14-512175 | 4.0MM X 75MM UNIPLANAR SCREW | In distribution |
| 14-503425 | 6.5 X 25MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-512595 | 7.5MM X 95MM UNIPLANAR SCREW | In distribution |
| 14-503530 | 7.5 X 30MM MULTIAXIAL ILIAC | In distribution |
| 14-500311 | DIA 7.5MM X 65MM MULTIAXIAL | In distribution |
| 5006752E | Cross Connector, Small | In distribution |
| 14-512455R | 6.5MM X 55MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-512440 | 6.5MM X 40MM UNIPLANAR SCREW | In distribution |
| 14-512485R | 6.5MM X 85MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-504750 | 9.5MM X 50MM FIXED SCREW 5.5 SST | In distribution |
| 14-578295 | 5.5 TI 4.75X95MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-503860 | 10.5 X 60MM MULTIAXIAL ILIAC | In distribution |
| 14-503140 | 4.0 X 40MM MULTIAXIAL ILIAC | In distribution |
| 14-500750E | 3.5 mm x 3.5 mm Axial, Ti Domino | In distribution |
| 2000-7598 | 7.5MM X 100MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 2000-7651 | 8.5MM X 50MM REDUCTION SCREW | In distribution |
| 2000-5556E | EXTENDED LAMINAR HOOK, MEDIUM | In distribution |
| 14-504180 | 4.0MM X 80MM FIXED SCREW 5.5 | In distribution |
| 2000-2735 | 9.5X35MM MULTIAXIAL SCREW | In distribution |
| 2000-5175 | 75MM TI ALLOY CURVED ROD | In distribution |
| 14-578520R | 5.5 TI 7.5X20MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-578805 | 5.5 TI 10.5 X125MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-504480 | 6.5MM X 80MM FIXED SCREW 5.5 | In distribution |
| 14-504545 | 7.5MM X 45MM FIXED SCREW 5.5 SST | In distribution |
| 14-504650 | 8.5MM X 50MM FIXED SCREW 5.5 | In distribution |
| 2000-4630 | 8.5 X 30MM FIXED SCREW | In distribution |
| 2000-7625C | SCREW, 8.5MM X 25MM MULTIAXIAL | In distribution |
| 2000-7345 | 5.5X45MM MULTIAXIAL RED.SCREW | In distribution |
| 14-578780 | 5.5 TI 9.5 X 80MM TRANSLATION TRANSLATION SCREW | In distribution |
| 2000-4130E | 4.0 mm ø. x 30 mm Fixed Screw | In distribution |
| 14-505560 | LEFT TRANSVERSE PROCESS HOOK | In distribution |
| 14-512760R | 9.5MM X 60MM REDUCTION | In distribution |
| 14-504385 | 5.5MM X 85MM FIXED SCREW 5.5 | In distribution |
| 2000-5313 | 120MM CP TI CURVED ROD | In distribution |
| 94494 | 28MM FIXED CROSS CONNECTOR | In distribution |
| 14-510120 | 120MM 5.5 TI ALLOY ROD W/HEX AND ORIENTATION MARKERS | In distribution |
| 2000-5411 | 110MM TI ALLOY CURVED ROD WITH HEX | In distribution |
| 2000-7230 | 4.75X30MM MULTIAXIAL RED.SCREW | In distribution |
| 2000-4235E | 4.75 X 35MM FIXED SCREW | In distribution |
| 14-512625R | 8.5MM X 20MM REDUCTION UNIPLANAR SCREW | In distribution |
| 2000-4645E | 8.5 x 45 mm Fixed Screw | In distribution |
| 2000-7775 | 9.5X75MM MULTIAXIAL RED.SCREW | In distribution |
| 2000-7790 | 9.5X90MM MULTIAXIAL RED.SCREW | In distribution |
| 14-512650R | 8.5MM X 50MM REDUCTION | In distribution |
| 2000-2765 | 9.5X65MM MULTIAXIAL SCREW | In distribution |
| 14-503630 | 8.5 X 30MM MULTIAXIAL ILIAC | In distribution |
| 14-512185R | 4.0MM X 85MM REDUCTION | In distribution |
| 2000-7381 | 5.5MM X 80MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 2000-2795 | 9.5X95MM MULTIAXIAL SCREW | In distribution |
| 14-504220 | 4.75MM X 20MM FIXED SCREW 5.5 SST | In distribution |
| 14-504675 | 8.5MM X 75MM FIXED SCREW 5.5 | In distribution |
| 2000-5516 | RIGHT ANGLED HOOK, LARGE(9MM) | In distribution |
| 14-504275 | 4.75MM X 75MM FIXED SCREW 5.5 | In distribution |
| 14-505124 | 50MM LATERAL CONNECTOR, | In distribution |
| 2000-7671 | 8.5MM X 65MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 2000-5305E | 510 mm CP Ti Rod w/ Hex | In distribution |
| 14-500364 | DIA 10.5MM X 30MM MULTIAXIAL | In distribution |
| 14-504345 | 5.5MM X 45MM FIXED SCREW 5.5 SST | In distribution |
| 2000-7541E | 7.5 mm x 40 mm Reduction Screw Multiaxial, Double Lead | In distribution |
| 2000-7745 | 9.5X45MM MULTIAXIAL RED.SCREW | In distribution |
| 14-504235 | 4.75MM X 35MM FIXED SCREW 5.5 | In distribution |
| 14-503440 | 6.5 X 40MM MULTIAXIAL ILIAC | In distribution |
| 2000-4575 | 7.5 X 75MM FIXED SCREW | In distribution |
| 14-512740 | 9.5MM X 40MM UNIPLANAR SCREW | In distribution |
| 2000-7341 | 5.5MM X 40MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 14-578325 | 5.5 TI 5.5X25MM TRANSLATION TRANSLATION SCREW | In distribution |
| 2000-7865 | 10.5X65MM MULTIAXIAL RED.SCREW | In distribution |
| 14-512475R | 6.5MM X 75MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-503575 | 7.5 X 75MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 2000-7446 | 6.5MM X 45MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 14-578309 | 5.5 TI 5.5X145MM TRANSLATION TRANSLATION SCREW | In distribution |
| 2000-2820 | 10.5X20MM MULTIAXIAL SCREW | In distribution |
| 2000-7326 | 5.5MM X 25MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 2000-7746 | 9.5MM X 45MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 2000-4560 | 7.5 X 60MM FIXED SCREW | In distribution |
| 14-578720R | 5.5 TI 9.5X20MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-512240R | 4.75MM X 40MM REDUCTION | In distribution |
| 14-502530 | 7.5 X 30MM MULTIAXIAL SCREW 5.5 SST | In distribution |
| 14-505546 | RIGHT OFFSET HOOK-5.5 SST | In distribution |
| 14-578506R | 5.5 TI 7.5X130MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-504885 | 10.5MM X 85MM FIXED SCREW 5.5 SST | In distribution |
| 14-504565 | 7.5MM X 65MM FIXED SCREW 5.5 SST | In distribution |
| 14-578806 | 5.5 TI 10.5 X130MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-512235RE | 4.75MM X 35MM REDUCTION | In distribution |
| 14-502535 | 7.5 X 35MM MULTIAXIAL SCREW 5.5 SST | In distribution |
| 2000-7735C | SCREW, 9.5MM X 35MM MULTIAXIAL | In distribution |
| 14-578855R | 5.5 TI 10.5X55MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 2000-5311 | 110MM CP TI CURVED ROD WITH HEX | In distribution |
| 14-512435E | 6.5MM X 35MM UNIPLANAR SCREW | In distribution |
| 2000-5145 | 45MM TI ALLOY CURVED ROD | In distribution |
| 2000-7560C | SCREW, 7.5MM X 60MM MULTIAXIAL | In distribution |
| 14-503390 | 5.5 X 90MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 2000-7545C | SCREW, 7.5MM X 45MM MULTIAXIAL CANNULATED REDUCTION | In distribution |
| 2000-7390C | SCREW, 5.5MM X 90MM MULTIAXIAL CANNULATED REDUCTION | In distribution |
| 2000-4655E | 8.5 X 55MM FIXED SCREW | In distribution |
| 14-500245 | DIA 4.75MM X 35MM MULTIAXIAL ILIAC SCREW 5.5 | In distribution |
| 2000-7686 | 8.5MM X 85MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 14-502640 | 8.5 X 40MM MULTIAXIAL SCREW 5.5 SST | In distribution |
| 14-512875R | 10.5MM X 75MM REDUCTION | In distribution |
| 2000-7795C | SCREW, 9.5MM X 95MM MULTIAXIAL CANNULATED REDUCTION | In distribution |
| 14-503550 | 7.5 X 50MM MULTIAXIAL ILIAC | In distribution |
| 14-512155R | 4.0MM X 55MM REDUCTION UNIPLANAR SCREW | In distribution |
| 2000-7656 | 8.5MM X 55MM REDUCTION SCREW | In distribution |
| 14-500349 | DIA 9.5MM X 55MM MULTIAXIAL | In distribution |
| 2000-5011 | 110MM CP TI CURVED ROD | In distribution |
| 2000-5180 | 80MM TI ALLOY CURVED ROD | In distribution |
| 14-500313 | DIA 7.5MM X 75MM MULTIAXIAL | In distribution |
| 14-512455 | 6.5MM X 55MM UNIPLANAR SCREW | In distribution |
| 14-512295R | 4.75MM X 95MM REDUCTION UNIPLANAR SCREW | In distribution |
| 2000-4545E | 7.5 x 45 mm Fixed Screw | In distribution |
| 14-504785 | 9.5MM X 85MM FIXED SCREW 5.5 SST | In distribution |
| 94671 | SMALL CROSS CONNECTOR | In distribution |
| 14-512725R | 9.5MM X 25MM REDUCTION | In distribution |
| 14-512370R | 5.5MM X 70MM REDUCTION | In distribution |
| 2000-5155 | 55MM TI ALLOY CURVED ROD | In distribution |
| 2000-4650E | 8.5 x 50 mm Fixed Screw | In distribution |
| 14-578630 | 5.5 TI 8.5X30MM TRANSLATION TRANSLATION SCREW | In distribution |
| 2000-4690 | 8.5 X 90MM FIXED SCREW | In distribution |
| 2000-7480 | 6.5X80MM MULTIAXIAL RED.SCREW | In distribution |
| 14-578355R | 5.5 TI 5.5X55MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-504720 | 9.5MM X 20MM FIXED SCREW 5.5 | In distribution |
| 2000-2165 | 4.0MM DIA X 65MM STANDARD | In distribution |
| 2000-5522E | Wide Laminar Hook, Large (9 mm) | In distribution |
| 94492 | 26MM FIXED CROSS CONNECTOR SHORT | In distribution |
| 2000-7661 | 8.5MM X 60MM REDUCTION SCREW | In distribution |
| 2000-7471 | 6.5MM X 70MM REDUCTION SCREW | In distribution |
| 14-512125 | 4.0MM X 25MM UNIPLANAR SCREW | In distribution |
| 14-512160R | 4.0MM X 60MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-503560 | 7.5 X 60MM MULTIAXIAL ILIAC SCREW, 5.5 SST | In distribution |
| 2000-7655C | SCREW, 8.5MM X 55MM MULTIAXIAL | In distribution |
| 14-506650R | 8.5MM X 50MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-512870R | 10.5MM X 70MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-504350 | 5.5MM X 50MM FIXED SCREW 5.5 | In distribution |
| 14-512335R | 5.5MM X 35MM REDUCTION UNIPLANAR SCREW | In distribution |
| 2000-5495 | 95MM TI ALLOY CURVED ROD W/HEX | In distribution |
| 14-578220 | 5.5 TI 4.75X20MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-504370 | 5.5MM X 70MM FIXED SCREW 5.5 | In distribution |
| 2000-4285 | 4.75 X 85MM FIXED SCREW | In distribution |
| 2000-4535 | 7.5 X 35MM FIXED SCREW | In distribution |
| 14-503130 | 4.0 X 30MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-506240R | 4.75MM X 40MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-503255 | 4.75 X 55MM MULTIAXIAL ILIAC | In distribution |
| 2000-7650C | SCREW, 8.5MM X 50MM MULTIAXIAL | In distribution |
| 14-500354 | DIA 9.5MM X 80MM MULTIAXIAL ILIAC SCREW 5.5 | In distribution |
| 2000-5566 | RIGHT TRANSVERSE PROCESS HOOK, | In distribution |
| 14-504680 | 8.5MM X 80MM FIXED SCREW 5.5 SST | In distribution |
| 2000-7636 | 8.5MM X 35MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 2000-7680 | 8.5X80MM MULTIAXIAL RED.SCREW | In distribution |
| 14-500132E | LATERAL CONNECTOR, OPEN, 35MM | In distribution |
| 2000-2430 | 6.5X30MM MULTIAXIAL SCREW | In distribution |
| 14-504120 | 4.0MM X 20MM FIXED SCREW 5.5 | In distribution |
| 2000-5546 | RIGHT OFFSET HOOK, LARGE (9MM) | In distribution |
| 14-512230 | 4.75MM X 30MM UNIPLANAR SCREW | In distribution |
| 14-512335 | 5.5MM X 35MM UNIPLANAR SCREW | In distribution |
| 2000-7695 | 8.5X95MM MULTIAXIAL RED.SCREW | In distribution |
| 14-503535 | 7.5 X 35MM MULTIAXIAL ILIAC | In distribution |
| 14-506560R | 7.5MM X 60MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-505566 | RIGHT TRANSVERSE PROCESS HOOK 5.5, SST MEDIUM | In distribution |
| 2000-2555E | 7.5 X 55MM MULTIAXIAL SCREW | In distribution |
| 14-512575R | 7.5MM X 75MM REDUCTION | In distribution |
| 14-504170 | 4.0MM X 70MM FIXED SCREW 5.5 SST | In distribution |
| 2000-5552 | ANGLED BLADE HOOK, LARGE (9MM) | In distribution |
| 14-503285 | 4.75 X 85MM MULTIAXIAL ILIAC | In distribution |
| 2000-7355E | 5.5 x 55 mm Multiaxial Red.Screw | In distribution |
| 14-578303 | 5.5 TI 5.5X115MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-512140 | 4.0MM X 40MM UNIPLANAR SCREW | In distribution |
| 14-512835 | 10.5MM X 35 UNIPLANAR SCREW | In distribution |
| 14-506325R | 5.5MM X 25MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-512220 | 4.75MM X 20MM UNIPLANAR SCREW | In distribution |
| 2000-4850 | 10.5 X 50MM FIXED SCREW | In distribution |
| 2000-2230E | 4.75 x 30 mm Multiaxial Screw | In distribution |
| 14-512865 | 10.5MM X 65MM UNIPLANAR SCREW | In distribution |
| 2000-7391 | 5.5MM X 90MM REDUCTION SCREW | In distribution |
| 2000-2575 | 7.5X75MM MULTIAXIAL SCREW | In distribution |
| 14-503475 | 6.5 X 75MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-578385R | 5.5 TI 5.5X85MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 2000-7498 | 6.5MM X 100MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 2000-5514E | LEFT ANGLED HOOK, LARGE (9MM) | In distribution |
| 14-578435 | 5.5 TI 6.5X35MM TRANSLATION TRANSLATION SCREW | In distribution |
| 2000-4345E | 5.5 X 45MM FIXED SCREW | In distribution |
| 5006751 | CROSS CONNECTOR, XSMALL | In distribution |
| 14-512245E | 4.75MM X 45MM UNIPLANAR SCREW | In distribution |
| 14-512765R | 9.5MM X 65MM REDUCTION UNIPLANAR SCREW | In distribution |
| 2000-2345 | 5.5X45MM MULTIAXIAL SCREW | In distribution |
| 2000-4435 | 6.5 X 35MM FIXED SCREW | In distribution |
| 14-504375 | 5.5MM X 75MM FIXED SCREW 5.5 SST | In distribution |
| 2000-5502 | PEDICLE HOOK, MEDIUM (7.5MM) | In distribution |
| 2000-4630E | 8.5 X 30MM FIXED SCREW | In distribution |
| 2000-5005 | 510MM CP TI ROD | In distribution |
| 14-512460R | 6.5MM X 60MM REDUCTION | In distribution |
| 2000-7545E | 7.5X45MM MULTIAXIAL RED.SCREW | In distribution |
| 14-503730 | 9.5 X 30MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-504735 | 9.5MM X 35MM FIXED SCREW 5.5 SST | In distribution |
| 14-500292E | 6.5 mm ø x 70 mm Multiaxial Iliac Screw | In distribution |
| 14-503690 | 8.5 X 90MM MULTIAXIAL ILIAC | In distribution |
| 14-503135 | 4.0 X 35MM MULTIAXIAL ILIAC | In distribution |
| 14-505542 | RIGHT OFFSET HOOK-5.5 SST MEDIUM | In distribution |
| 14-503230 | 4.75 X 30MM MULTIAXIAL ILIAC | In distribution |
| 14-507355 | 5.5 X 55MM MULTIAXIAL REDUCTION SCREW, 5.5 SST | In distribution |
| 2000-7851 | 10.5MM X 50MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 14-578607 | 5.5 TI 8.5X135MM TRANSLATION TRANSLATION SCREW | In distribution |
| 2000-7520 | 7.5X20MM MULTIAXIAL RED.SCREW | In distribution |
| 2000-7756 | 9.5MM X 55MM REDUCTION SCREW | In distribution |
| 2000-7626 | 8.5MM X 25MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 14-504850 | 10.5MM X 50MM FIXED SCREW 5.5 | In distribution |
| 94673 | LARGE CROSS CONNECTOR | In distribution |
| 2000-7785C | SCREW, 9.5MM X 85MM MULTIAXIAL CANNULATED REDUCTION | In distribution |
| 14-503395 | 5.5 X 95MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 2000-7281 | 4.75MM X 80MM REDUCTION SCREW | In distribution |
| 2000-5510E | Left Angled Hook, Medium (7.5 mm) | In distribution |
| 2000-5170E | 70MM TI ALLOY CURVED ROD | In distribution |
| 14-500290 | DIA 6.5MM X 60MM MULTIAXIAL | In distribution |
| 2000-4890 | 10.5 X 90MM FIXED SCREW | In distribution |
| 14-506640R | 8.5MM X 40MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-500248 | DIA 4.75MM X 50MM MULTIAXIAL ILIAC SCREW 5.5 | In distribution |
| 14-504345 | 5.5MM X 45MM FIXED SCREW 5.5 | In distribution |
| 14-578704R | 5.5 TI 9.5X120MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-506460R | 6.5MM X 60MM REDUCTION UNIPLANAR SCREW | In distribution |
| 2000-7665C | SCREW, 8.5MM X 65MM MULTIAXIAL | In distribution |
| 2000-7855 | 10.5X55MM MULTIAXIAL RED.SCREW | In distribution |
| 14-512585 | 7.5MM X 85MM UNIPLANAR SCREW | In distribution |
| 14-512535R | 7.5MM X 35MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-504195 | 4.0MM X 95MM FIXED SCREW 5.5 | In distribution |
| 14-578310R | 5.5 TI 5.5X150MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 2000-5534 | NARROW REDUCED LAMINAR HOOK, | In distribution |
| 2000-7490C | SCREW, 6.5MM X 90MM MULTIAXIAL CANNULATED REDUCTION | In distribution |
| 14-500352 | DIA 9.5MM X 70MM MULTIAXIAL | In distribution |
| 2000-7655 | 8.5X55MM MULTIAXIAL RED.SCREW | In distribution |
| 14-503475 | 6.5 X 75MM MULTIAXIAL ILIAC | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151974 | 2015-11-13 |
| K141804 | 2014-09-25 |
| K121130 | 2012-06-15 |
| K091067 | 2009-07-14 |
| K081952 | 2008-10-07 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2015-03-12 | Class II | Nonconforming Material/Component | Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification. | 4,765 units | 2015-12-21 |
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.