Polaris™ 5.5 Spinal System
731 catalogue numbers from 14-506230R, 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
731catalogue 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 | 2020-06-24 |
| 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 |
|---|---|---|
| 14-506230R | 4.75MM X 30MM REDUCTION UNIPLANAR SCREW | In distribution |
| 2000-4580 | 7.5 X 80MM FIXED SCREW | In distribution |
| 14-512755 | 9.5MM X 55MM UNIPLANAR SCREW | In distribution |
| 14-506735R | 9.5MM X 35MM REDUCTION UNIPLANAR SCREW | In distribution |
| 2000-2845 | 10.5X45MM MULTIAXIAL SCREW | In distribution |
| 14-512655R | 8.5MM X 55MM REDUCTION UNIPLANAR SCREW | In distribution |
| 2000-7555C | SCREW, 7.5MM X 55MM MULTIAXIAL CANNULATED REDUCTION | In distribution |
| 2000-4280 | 4.75 X 80MM FIXED SCREW | In distribution |
| 14-503580 | 7.5 X 80MM MULTIAXIAL ILIAC SCREW, 5.5 SST | In distribution |
| 2000-4440 | 6.5 X 40MM FIXED SCREW | In distribution |
| 2000-7481 | 6.5MM X 80MM REDUCTION SCREW | In distribution |
| 14-504235 | 4.75MM X 35MM FIXED SCREW 5.5 SST | In distribution |
| 2000-7698 | 8.5MM X 100MM REDUCTION SCREW | In distribution |
| 14-500308 | DIA 7.5MM X 50MM MULTIAXIAL ILIAC SCREW 5.5 | In distribution |
| 14-512845 | 10.5MM X 45MM UNIPLANAR SCREW | In distribution |
| 14-578402R | 5.5 TI 6.5X110MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 2000-7770C | SCREW, 9.5MM X 70MM MULTIAXIAL | In distribution |
| 14-512690R | 8.5MM X 90MM REDUCTION UNIPLANAR SCREW | In distribution |
| 2000-4650 | 8.5 X 50MM FIXED SCREW | In distribution |
| 14-512799R | 9.5MM X 100MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-503725 | 9.5 X 25MM MULTIAXIAL ILIAC | In distribution |
| 2000-7226 | 4.75MM X 25MM REDUCTION SCREW | In distribution |
| 2000-7566 | 7.5MM X 65MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 2000-7820 | 10.5X20MM MULTIAXIAL RED.SCREW | In distribution |
| 2000-7555E | 7.5 x 55 mm Multiaxial Red.Screw | In distribution |
| 2000-4350E | 5.5 x 50 mm Fixed Screw | In distribution |
| 2000-2170 | 4.0MM DIA X 70MM STANDARD MULTIAXIAL SCREW | In distribution |
| 2000-2220E | 4.75 X 20MM MULTIAXIAL SCREW | In distribution |
| 14-578302 | 5.5 TI 5.5X110MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-504640 | 8.5MM X 40MM FIXED SCREW 5.5 SST | In distribution |
| 14-500310E | 7.5 mm ø x 60 mm Multiaxial Iliac Screw | In distribution |
| 14-578245 | 5.5 TI 4.75X45MM TRANSLATION TRANSLATION SCREW | In distribution |
| 2000-7625 | 8.5X25MM MULTIAXIAL RED.SCREW | In distribution |
| 2000-4435E | 6.5 X 35MM FIXED SCREW | In distribution |
| 2000-2535E | 7.5 x 35 mm Multiaxial Screw | In distribution |
| 2000-7881 | 10.5MM X 80MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 14-500316E | 7.5MM DIA X 90MM MULTIAXIAL | In distribution |
| 14-512385R | 5.5MM X 85MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-578365 | 5.5 TI 5.5X65MM TRANSLATION TRANSLATION SCREW | In distribution |
| 2000-5110 | 105MM TI ALLOY CURVED ROD | In distribution |
| 2000-2230 | 4.75X30MM MULTIAXIAL SCREW | In distribution |
| 14-500302 | DIA 7.5MM X 20MM MULTIAXIAL | In distribution |
| 14-506525R | 6.5MM X 25MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-578870 | 5.5 TI 10.5 X 70MM TRANSLATION TRANSLATION SCREW | In distribution |
| 2000-4160 | 4.0MM DIA. X 60MM FIXED SCREW | In distribution |
| 2000-5310 | 105MM CP TI CURVED ROD | In distribution |
| 14-512350R | 5.5MM X 50MM REDUCTION | In distribution |
| 2000-7340E | 5.5 x 40 mm Multiaxial Red.Screw | In distribution |
| 2000-5544E | LEFT OFFSET HOOK, LARGE (9MM) | In distribution |
| 2000-5411 | 110MM TI ALLOY CURVED ROD | In distribution |
| 14-512840R | 10.5MM X 40MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-500132 | LATERAL CONNECTOR, OPEN, 35MM | In distribution |
| 2000-4695 | 8.5 X 95MM FIXED SCREW | In distribution |
| 14-504145 | 4.0MM X 45MM FIXED SCREW 5.5 | In distribution |
| 14-512375 | 5.5MM X 75MM UNIPLANAR SCREW | In distribution |
| 14-512725 | 9.5MM X 25MM UNIPLANAR SCREW | In distribution |
| 2000-7365C | SCREW, 5.5MM X 65MM MULTIAXIAL | In distribution |
| 2000-5518 | WIDE LAMINAR HOOK, SMALL (6MM) | In distribution |
| 2000-2785 | 9.5X85MM MULTIAXIAL SCREW | In distribution |
| 14-503750 | 9.5 X 50MM MULTIAXIAL ILIAC | In distribution |
| 2000-2355E | 5.5 X 55MM MULTIAXIAL SCREW | In distribution |
| 5006751 | CROSS CONNECTOR, XSMALL | In distribution |
| 2000-7320 | 5.5X20MM MULTIAXIAL RED.SCREW | In distribution |
| 14-500310E | 7.5MM DIA X 60MM MULTIAXIAL | In distribution |
| 14-578760R | 5.5 TI 9.5X60MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 2000-7431 | 6.5MM X 30MM REDUCTION SCREW | In distribution |
| 14-500245 | DIA 4.75MM X 35MM MULTIAXIAL | In distribution |
| 2000-7540 | 7.5X40MM MULTIAXIAL RED.SCREW | In distribution |
| 14-578640R | 5.5 TI 8.5X40MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 2000-2745 | 9.5X45MM MULTIAXIAL SCREW | In distribution |
| 14-512255R | 4.75MM X 50MM REDUCTION | In distribution |
| 14-578805R | 5.5 TI 10.5X125MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 2000-7440 | 6.5X40MM MULTIAXIAL RED.SCREW | In distribution |
| 14-500370 | DIA 10.5MM X 60MM MULTIAXIAL | In distribution |
| 2000-7420 | 6.5X20MM MULTIAXIAL RED.SCREW | In distribution |
| 14-503595 | 7.5 X 95MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-503250 | 4.75 X 50MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 2000-7860 | 10.5X60MM MULTIAXIAL RED.SCREW | In distribution |
| 14-578250 | 5.5 TI 4.75X50MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-505560 | LEFT TRANSVERSE PROCESS HOOK 5.5, SST SMALL | In distribution |
| 2000-4340 | 5.5 X 40MM FIXED SCREW | In distribution |
| 2000-7435 | 6.5X35MM MULTIAXIAL RED.SCREW | In distribution |
| 14-504845 | 10.5MM X 45MM FIXED SCREW 5.5 SST | In distribution |
| 94489 | 20MM FIXED CROSS CONNECTOR | In distribution |
| 14-506135R | 4.0MM X 35MM REDUCTION UNIPLANAR SCREW | In distribution |
| 2000-7691 | 8.5MM X 90MM REDUCTION SCREW | In distribution |
| 14-512360R | 5.5MM X 60MM REDUCTION | In distribution |
| 2000-7441E | 6.5MM X 40MM REDUCTION SCREW | In distribution |
| 14-500130E | 12MM FIXED CROSS CONNECTOR | In distribution |
| 2000-7880 | 10.5X80MM MULTIAXIAL RED.SCREW | In distribution |
| 14-500295 | DIA 6.5MM X 85MM MULTIAXIAL ILIAC SCREW 5.5 | In distribution |
| 2000-5312 | 115MM CP TI CURVED ROD WITH HEX | In distribution |
| 14-578510 | 5.5 TI 7.5X150MM TRANSLATION TRANSLATION SCREW | In distribution |
| 2000-2265 | 4.75X65MM MULTIAXIAL SCREW | In distribution |
| 14-512595R | 7.5MM X 95MM REDUCTION | In distribution |
| 2000-2499 | 6.5X100MM MULTIAXIAL SCREW | In distribution |
| 14-504425 | 6.5MM X 25MM FIXED SCREW 5.5 | In distribution |
| 14-512495R | 6.5MM X 95MM REDUCTION | In distribution |
| 14-500307 | DIA 7.5MM X 45MM MULTIAXIAL ILIAC SCREW 5.5 | In distribution |
| 14-578880R | 5.5 TI 10.5X80MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 2000-7385 | 5.5X85MM MULTIAXIAL RED.SCREW | In distribution |
| 14-506520R | 7.5MM X 20MM REDUCTION UNIPLANAR SCREW | In distribution |
| 2000-5140 | 40MM TI ALLOY CURVED ROD | In distribution |
| 2000-4175 | 4.0MM DIA. X 75MM FIXED SCREW | In distribution |
| 2000-5030 | 30MM CP TI CURVED ROD | In distribution |
| 2000-7455E | 6.5X55MM MULTIAXIAL RED.SCREW | In distribution |
| 2000-5135E | 35 mm Ti Alloy Curved Rod | In distribution |
| 14-578205R | 5.5 TI 4.75X125MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-512435RE | 6.5MM X 35MM REDUCTION | In distribution |
| 2000-2245E | 4.75 x 45 mm Multiaxial Screw | In distribution |
| 14-512250R | 4.75MM X 50MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-503890 | 10.5 X 90MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-504795 | 9.5MM X 95MM FIXED SCREW 5.5 | In distribution |
| 14-503899 | 10.5 X 100MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-503320 | 5.5 X 20MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-500253 | DIA 4.75MM X 75MM MULTIAXIAL ILIAC SCREW 5.5 | In distribution |
| 2000-7361 | 5.5MM X 60MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 14-578645 | 5.5 TI 8.5X45MM TRANSLATION TRANSLATION SCREW | In distribution |
| 2000-7791 | 9.5MM X 85MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 2000-7556 | 7.5MM X 55MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 2000-4440E | 6.5 X 40MM FIXED SCREW | In distribution |
| 2000-2845 | 10.5X45MM MULTIAXIAL SCREW | In distribution |
| 2000-7785 | 9.5X85MM MULTIAXIAL RED.SCREW | In distribution |
| 14-504130 | 4.0MM X 30MM FIXED SCREW 5.5 SST | In distribution |
| 2000-4795 | 9.5 X 95MM FIXED SCREW | In distribution |
| 2000-4230 | 4.75 X 30MM FIXED SCREW | In distribution |
| 14-512630R | 8.5MM X 30MM REDUCTION | In distribution |
| 2000-4140 | 4.0MM DIA. X 40MM FIXED SCREW | In distribution |
| 2000-5537R | Right Extd Offset Hook, Small (6.0 mm) | In distribution |
| 2000-7395C | SCREW, 5.5MM X 95MM MULTIAXIAL | In distribution |
| 2000-7561 | 7.5MM X 60MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 2000-7641 | 8.5MM X 40MM REDUCTION SCREW | In distribution |
| 14-512680R | 8.5MM X 80MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-500324 | DIA 8.5MM X 30MM MULTIAXIAL ILIAC SCREW 5.5 | In distribution |
| 14-500346 | DIA 9.5MM X 40MM MULTIAXIAL | In distribution |
| 2000-7855C | SCREW,10.5MM X 55MM MULTIAXIAL CANNULATED REDUCTION | In distribution |
| 2000-2185 | 4.0MM DIA X 85MM STANDARD | In distribution |
| 14-578705R | 5.5 TI 9.5X125MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 2000-2595 | 7.5X95MM MULTIAXIAL SCREW | In distribution |
| 14-504670 | 8.5MM X 70MM FIXED SCREW 5.5 | In distribution |
| 14-502140 | 4.0 X 40MM MULTIAXIAL SCREW 5.5 SST | In distribution |
| 2000-7551 | 7.5MM X 50MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 2000-7251 | 4.75MM X 50MM REDUCTION SCREW | In distribution |
| 14-504840 | 10.5MM X 40MM FIXED SCREW 5.5 SST | In distribution |
| 14-512140E | 4.0MM X 40MM UNIPLANAR SCREW | In distribution |
| 2000-7355E | 5.5X55MM MULTIAXIAL RED.SCREW | In distribution |
| 2000-5099 | 100MM CP TI CURVED ROD | In distribution |
| 2000-7275 | 4.75X75MM MULTIAXIAL RED.SCREW | In distribution |
| 2000-7430C | SCREW, 6.5MM X 30MM MULTIAXIAL CANNULATED REDUCTION | In distribution |
| 2000-5540 | LEFT OFFSET HOOK, MEDIUM | In distribution |
| 14-578620 | 5.5 TI 8.5X20MM TRANSLATION TRANSLATION SCREW | In distribution |
| 2000-5445 | 45MM TI ALLOY CURVED ROD W/HEX | In distribution |
| 2000-4825 | 10.5 X 25MM FIXED SCREW | In distribution |
| 2000-7699 | 8.5X100MM MULTIAXIAL RED.SCREW | In distribution |
| 14-503145 | 4.0 X 45MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 2000-7865 | 10.5X65MM MULTIAXIAL RED.SCREW | In distribution |
| 2000-2755 | 9.5X55MM MULTIAXIAL SCREW | In distribution |
| 14-505504 | PEDICLE HOOK- 5.5 SST (LARGE) | In distribution |
| 14-503150 | 4.0 X 50MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 2000-7591 | 7.5MM X 90MM REDUCTION SCREW | In distribution |
| 14-500306 | DIA 7.5MM X 40MM MULTIAXIAL ILIAC SCREW 5.5 | In distribution |
| 14-512470R | 6.5MM X 70MM REDUCTION UNIPLANAR SCREW | In distribution |
| 2000-7326 | 5.5MM X 25MM REDUCTION SCREW | In distribution |
| 2000-7240 | 4.75X40MM MULTIAXIAL RED.SCREW | In distribution |
| 14-500287 | DIA 6.5MM X 45MM MULTIAXIAL | In distribution |
| 14-506175R | 4.0MM X 75MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-500256 | DIA 4.75MM X 90MM MULTIAXIAL ILIAC SCREW 5.5 | In distribution |
| 14-506360R | 5.5MM X 60MM REDUCTION UNIPLANAR SCREW | In distribution |
| 2000-2235E | 4.75 X 35MM MULTIAXIAL SCREW | In distribution |
| 14-512150R | 4.0MM X 50MM REDUCTION | In distribution |
| 2000-4480 | 6.5 X 80MM FIXED SCREW | In distribution |
| 2000-7495 | 6.5X95MM MULTIAXIAL RED.SCREW | In distribution |
| 2000-7870 | 10.5X70MM MULTIAXIAL RED.SCREW | In distribution |
| 14-503485 | 6.5 X 85MM MULTIAXIAL ILIAC | In distribution |
| 2000-7380 | 5.5X80MM MULTIAXIAL RED.SCREW | In distribution |
| 14-512235R | 4.75MM X 35MM REDUCTION | In distribution |
| 2000-7530C | SCREW, 7.5MM X 30MM MULTIAXIAL | In distribution |
| 2000-5430 | 30MM TI ALLOY CURVED ROD W/HEX | In distribution |
| 14-505532 | NARROW REDUCED LAMINAR HOOK | In distribution |
| 2000-5554E | Extended Laminar Hook, Small (6 mm) | In distribution |
| 14-578785 | 5.5 TI 9.5 X 85MM TRANSLATION TRANSLATION SCREW | In distribution |
| 14-504795 | 9.5MM X 95MM FIXED SCREW 5.5 SST | In distribution |
| 14-500330E | 8.5MM DIA X 60MM MULTIAXIAL | In distribution |
| 14-512265R | 4.75MM X 65MM REDUCTION | In distribution |
| 5006750 | CROSS CONNECTOR, XXSMALL | In distribution |
| 14-503370 | 5.5 X 70MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-512899R | 10.5MM X 100MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-500345 | DIA 9.5MM X 35MM MULTIAXIAL | In distribution |
| 2000-2795 | 9.5X95MM MULTIAXIAL SCREW | In distribution |
| 2000-7586 | 7.5MM X 85MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 2000-5035 | 35MM CP TI CURVED ROD | In distribution |
| 5006751E | Cross Connector, X-Small | In distribution |
| 14-505554 | EXTENDED LAMINAR HOOK 5.5 SST SMALL | In distribution |
| 14-578603R | 5.5 TI 8.5X115MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 14-505536 | LEFT OFFSET HOOK-5.5 SST | In distribution |
| 5006754E | Cross Connector, Large | In distribution |
| 2000-5558 | EXTENDED LAMINAR HOOK, LARGE (9MM) | In distribution |
| 2000-4445 | 6.5 X 45MM FIXED SCREW | In distribution |
| 14-500365 | DIA 10.5MM X 35MM MULTIAXIAL ILIAC SCREW 5.5 | In distribution |
| 2000-5165E | 65 mm Ti Alloy Curved Rod | In distribution |
| 14-512635R | 8.5MM X 35MM REDUCTION UNIPLANAR SCREW | In distribution |
| 2000-4820 | 10.5 X 20MM FIXED SCREW | In distribution |
| 2000-7265 | 4.75X65MM MULTIAXIAL RED.SCREW | In distribution |
| 2000-7570C | SCREW, 7.5MM X 70MM MULTIAXIAL CANNULATED REDUCTION | In distribution |
| 2000-7545 | 7.5X45MM MULTIAXIAL RED.SCREW | In distribution |
| 2000-7525C | SCREW, 7.5MM X 25MM MULTIAXIAL CANNULATED REDUCTION | In distribution |
| 14-504555 | 7.5MM X 55MM FIXED SCREW 5.5 | In distribution |
| 14-504299 | 4.75MM X 100MM FIXED SCREW 5.5 | In distribution |
| 14-504685 | 8.5MM X 85MM FIXED SCREW 5.5 SST | In distribution |
| 14-502230 | 4.75 X 30MM MULTIAXIAL SCREW 5.5 SST | In distribution |
| 14-500322 | DIA 8.5MM X 20MM MULTIAXIAL ILIAC SCREW 5.5 | In distribution |
| 14-512270R | 4.75MM X 70MM REDUCTION UNIPLANAR SCREW | In distribution |
| 14-578707R | 5.5 TI 9.5X135MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 2000-7221 | 4.75MM X 20MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD | In distribution |
| 2000-7899 | 10.5X100MM MULTIAXIAL RED. | In distribution |
| 2000-4550 | 7.5 X 50MM FIXED SCREW | In distribution |
| 14-505520 | WIDE LAMINAR HOOK-5.5 SST MEDIUM | In distribution |
| 14-503885 | 10.5 X 85MM MULTIAXIAL ILIAC SCREW, SST | In distribution |
| 14-507545 | 7.5 X 45MM MULTIAXIAL REDUCTION SCREW, 5.5 SST | In distribution |
| 2000-2485 | 6.5X85MM MULTIAXIAL SCREW | In distribution |
| 14-502630 | 8.5 X 30MM MULTIAXIAL SCREW 5.5 SST | In distribution |
| 14-500764E | 4.75 mm x 6.35 mm Axial, Ti Domino | In distribution |
| 2000-7540C | SCREW, 7.5MM X 40MM MULTIAXIAL CANNULATED REDUCTION | In distribution |
| 14-578490 | 5.5 TI 6.5X90MM TRANSLATION TRANSLATION SCREW | In distribution |
| 2000-7430E | 6.5X30MM MULTIAXIAL RED.SCREW | In distribution |
| 14-512830R | 10.5MM X 30MM REDUCTION | In distribution |
| 2000-4255 | 4.75 X 55MM FIXED SCREW | In distribution |
| 2000-7320 | 5.5X20MM MULTIAXIAL RED.SCREW | In distribution |
| 2000-7580C | SCREW, 7.5MM X 80MM MULTIAXIAL | In distribution |
| 14-500296E | 6.5 mm ø x 90 mm Multiaxial Iliac Screw | In distribution |
| 14-504730 | 9.5MM X 30MM FIXED SCREW 5.5 SST | In distribution |
| 2000-5110 | 105MM TI ALLOY CURVED ROD | In distribution |
| 14-505120 | 25MM LATERAL CONNECTOR, | In distribution |
| 2000-4145 | 4.0MM DIA. X 45MM FIXED SCREW | In distribution |
| 14-512430R | 6.5MM X 30MM REDUCTION | In distribution |
| 2000-7745C | SCREW, 9.5MM X 45MM MULTIAXIAL | In distribution |
| 2000-5135 | 35MM TI ALLOY CURVED ROD | In distribution |
| 14-505403 | 610MM ROD, MEDIUM, W/HEX, SST | In distribution |
| 2000-2655 | 8.5X55MM MULTIAXIAL SCREW | In distribution |
| 14-503445 | 6.5 X 45MM MULTIAXIAL ILIAC | In distribution |
| 2000-5150E | 50 mm Ti Alloy Curved Rod | In distribution |
| 2000-7496 | 6.5MM X 95MM REDUCTION SCREW | In distribution |
| 2000-4580 | 7.5 X 80MM FIXED SCREW | In distribution |
| 14-578607R | 5.5 TI 8.5X135MM TRANS REDUC TRANSLATION REDUCTION SCREW | In distribution |
| 2000-5475 | 75MM TI ALLOY CURVED ROD W/HEX | In distribution |
| 14-512899R | 10.5MM X 100MM REDUCTION | In distribution |
| 2000-7345E | 5.5 x 45 mm Multiaxial Red.Screw | In distribution |
| 14-512285R | 4.75MM X 85MM REDUCTION UNIPLANAR SCREW | In distribution |
| 2000-5539L | Left Extd Offset Hook, Medium (7.5 mm) | In distribution |
| 14-578202 | 5.5 TI 4.75X110MM TRANSLATION TRANSLATION SCREW | 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.