Polaris 5.5 Spinal Fixation System
5.5 HA Multi Screw 7.5 X 55MM Dual-Lead, Balanced-Start TIP
15manufacturers in China registered for this device type
1,219catalogue numbers in this listing
1510(k) clearance
4recalls on this code
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 | Highridge Medical, LLC, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2025-11-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-500839 | Device Size Text, specify—3.5MM X 5.5MM PARALLEL TI | In distribution |
| 14-500766 | Device Size Text, specify—5.5MM X 6.0MM AXIAL,TI | In distribution |
| 2000-4620 | Device Size Text, specify—8.5 X 20MM FIXED SCREW | In distribution |
| 14-512890 | Device Size Text, specify—10.5MM X 90MM UNIPLANAR SCREW | In distribution |
| 2000-4370 | Device Size Text, specify—5.5 X 70MM FIXED SCREW | In distribution |
| 14-510645R | Device Size Text, specify—5.5 TI 6.5X45MM TAPERED REDUC | In distribution |
| 2000-4345 | Device Size Text, specify—5.5 X 45MM FIXED SCREW | In distribution |
| 2000-5524E | In distribution | |
| 14-592675 | Device Size Text, specify—5.5 HA MULTI SCREW 8.5 X 75MM | In distribution |
| 2000-2699 | Device Size Text, specify—8.5X100MM MULTIAXIAL SCREW | In distribution |
| 14-512435E | In distribution | |
| 14-512875 | Device Size Text, specify—10.5MM X 75MM UNIPLANAR SCREW | In distribution |
| 14-500764 | Device Size Text, specify—4.75MM X 6.35MM AXIAL,TI | In distribution |
| 14-512850R | Device Size Text, specify—10.5MM X 50MM REDUCTION | In distribution |
| 14-592301 | Device Size Text, specify—5.5 HA MULTI SCREW 5.5 X105MM | In distribution |
| 2000-5106 | Device Size Text, specify—610MM TI ALLOY ROD | In distribution |
| 2000-7475 | Device Size Text, specify—6.5X75MM MULTIAXIAL RED.SCREW | In distribution |
| 14-500315 | Device Size Text, specify—DIA 7.5MM X 85MM MULTIAXIAL | In distribution |
| 2000-7495C | Device Size Text, specify—SCREW, 6.5MM X 95MM MULTIAXIAL | In distribution |
| 14-500761 | Device Size Text, specify—4.75MM X 4.75MM AXIAL,TI | In distribution |
| 2000-7395 | Device Size Text, specify—5.5X95MM MULTIAXIAL RED.SCREW | In distribution |
| 2000-4770 | Device Size Text, specify—9.5 X 70MM FIXED SCREW | In distribution |
| 14-512760 | Device Size Text, specify—9.5MM X 60MM UNIPLANAR SCREW | In distribution |
| 2000-2430E | In distribution | |
| 14-500312E | In distribution | |
| 14-512675 | Device Size Text, specify—8.5MM X 75MM UNIPLANAR SCREW | In distribution |
| 14-592607 | Device Size Text, specify—5.5 HA MULTI SCREW 8.5 X135MM | In distribution |
| 2000-5522E | In distribution | |
| 2000-7650 | Device Size Text, specify—8.5X50MM MULTIAXIAL RED.SCREW | In distribution |
| 14-578355 | Device Size Text, specify—5.5 TI 5.5X55MM TRANSLATION | In distribution |
| 2000-4555E | In distribution | |
| 2000-5110 | Device Size Text, specify—105MM TI ALLOY CURVED ROD | In distribution |
| 2000-5516E | In distribution | |
| 2000-7835C | Device Size Text, specify—SCREW,10.5MM X 35MM MULTIAXIAL | In distribution |
| 2000-7775 | Device Size Text, specify—9.5X75MM MULTIAXIAL RED.SCREW | In distribution |
| 2000-7670C | Device Size Text, specify—SCREW, 8.5MM X 70MM MULTIAXIAL | In distribution |
| 14-592360 | Device Size Text, specify—5.5 HA MULTI SCREW 5.5 X 60MM | In distribution |
| 2000-2270 | Device Size Text, specify—4.75X70MM MULTIAXIAL SCREW | In distribution |
| 14-500287 | Device Size Text, specify—DIA 6.5MM X 45MM MULTIAXIAL | In distribution |
| 14-500374 | Device Size Text, specify—DIA 10.5MM X 80MM MULTIAXIAL | In distribution |
| 14-592625 | Device Size Text, specify—5.5 HA MULTI SCREW 8.5 X 25MM | In distribution |
| 2000-2835 | Device Size Text, specify—10.5X35MM MULTIAXIAL SCREW | In distribution |
| 14-512240E | In distribution | |
| 14-512235E | In distribution | |
| 14-500338 | Device Size Text, specify—DIA 8.5MM X 100MM MULTIAXIAL | In distribution |
| 2000-4750 | Device Size Text, specify—9.5 X 50MM FIXED SCREW | In distribution |
| 2000-7475C | Device Size Text, specify—SCREW, 6.5MM X 75MM MULTIAXIAL | In distribution |
| 14-592670 | Device Size Text, specify—5.5 HA MULTI SCREW 8.5 X 70MM | In distribution |
| 14-500585E | In distribution | |
| 14-512230RE | In distribution | |
| 14-512570R | Device Size Text, specify—7.5MM X 75MM REDUCTION | In distribution |
| 14-592635 | Device Size Text, specify—5.5 HA MULTI SCREW 8.5 X 35MM | In distribution |
| 2000-7270 | Device Size Text, specify—4.75X70MM MULTIAXIAL RED.SCREW | In distribution |
| 14-512580R | Device Size Text, specify—7.5MM X 80MM REDUCTION | In distribution |
| 5006750E | In distribution | |
| 14-500357 | Device Size Text, specify—DIA 9.5MM X 95MM MULTIAXIAL | In distribution |
| 2000-2780 | Device Size Text, specify—9.5X80MM MULTIAXIAL SCREW | In distribution |
| 2000-7740 | Device Size Text, specify—9.5X40MM MULTIAXIAL RED.SCREW | In distribution |
| 2000-7865C | Device Size Text, specify—SCREW,10.5MM X 65MM MULTIAXIAL | In distribution |
| 2000-2680 | Device Size Text, specify—8.5X80MM MULTIAXIAL SCREW | In distribution |
| 2000-4570 | Device Size Text, specify—7.5 X 70MM FIXED SCREW | In distribution |
| 14-592555 | In distribution | |
| 2000-7765C | Device Size Text, specify—SCREW, 9.5MM X 65MM MULTIAXIAL | In distribution |
| 14-500762 | Device Size Text, specify—4.75MM X 5.5MM AXIAL,TI | In distribution |
| 14-510745R | Device Size Text, specify—5.5 TI 7.5X45MM TAPERED REDUC | In distribution |
| 2000-7899C | Device Size Text, specify—SCREW10.5MM X 100MM MULTIAXIAL | In distribution |
| 14-500296E | In distribution | |
| 14-500297 | Device Size Text, specify—DIA 6.5MM X 95MM MULTIAXIAL | In distribution |
| 2000-5552E | In distribution | |
| 2000-4880 | Device Size Text, specify—10.5 X 80MM FIXED SCREW | In distribution |
| 2000-5410 | Device Size Text, specify—105MM TI ALLOY CURVED ROD | In distribution |
| 2000-2320 | Device Size Text, specify—5.5X20MM MULTIAXIAL SCREW | In distribution |
| 2000-5305 | Device Size Text, specify—510MM CP TI ROD W/HEX | In distribution |
| 14-500754 | Device Size Text, specify—3.5MM X 6.0MM AXIAL,TI | In distribution |
| 14-592335 | In distribution | |
| 14-578555 | Device Size Text, specify—5.5 TI 7.5X55MM TRANSLATION | In distribution |
| 14-592695 | Device Size Text, specify—5.5 HA MULTI SCREW 8.5 X 95MM | In distribution |
| 2000-5114 | Device Size Text, specify—125MM TI ALLOY CURVED ROD | In distribution |
| 14-510740R | Device Size Text, specify—5.5 TI 7.5X40MM TAPERED REDUC | In distribution |
| 14-592475 | Device Size Text, specify—5.5 HA MULTI SCREW 6.5 X 75MM | In distribution |
| 2000-7320C | Device Size Text, specify—SCREW, 5.5MM X 20MM MULTIAXIAL | In distribution |
| 2000-7585C | Device Size Text, specify—SCREW, 7.5MM X 85MM MULTIAXIAL | In distribution |
| 14-512235RE | In distribution | |
| 14-512445RE | In distribution | |
| 2000-7660C | Device Size Text, specify—SCREW, 8.5MM X 60MM MULTIAXIAL | In distribution |
| 14-500328 | Device Size Text, specify—DIA 8.5MM X 50MM MULTIAXIAL | In distribution |
| 2000-5542E | In distribution | |
| 14-500303 | Device Size Text, specify—DIA 7.5MM X 25MM MULTIAXIAL | In distribution |
| 2000-7621 | Device Size Text, specify—8.5MM X 20MM REDUCTION SCREW | In distribution |
| 2000-7360C | Device Size Text, specify—SCREW, 5.5MM X 60MM MULTIAXIAL | In distribution |
| 2000-4645 | Device Size Text, specify—8.5 X 45MM FIXED SCREW | In distribution |
| 2000-7520 | Device Size Text, specify—7.5X20MM MULTIAXIAL RED.SCREW | In distribution |
| 14-592450 | In distribution | |
| 14-592510 | Device Size Text, specify—5.5 HA MULTI SCREW 7.5 X150MM | In distribution |
| 14-512330E | In distribution | |
| 14-500377 | Device Size Text, specify—DIA 10.5MM X 95MM MULTIAXIAL | In distribution |
| 14-512765 | Device Size Text, specify—9.5MM X 65MM UNIPLANAR SCREW | In distribution |
| 14-500294 | Device Size Text, specify—DIA 6.5MM X 80MM MULTIAXIAL | In distribution |
| 2000-7340C | Device Size Text, specify—SCREW, 5.5MM X 40MM MULTIAXIAL | In distribution |
| 2000-5530 | Device Size Text, specify—NARROW REDUCED LAMINAR HOOK, | In distribution |
| 2000-7590 | Device Size Text, specify—7.5X90MM MULTIAXIAL RED.SCREW | In distribution |
| 14-500285 | Device Size Text, specify—DIA 6.5MM X 35MM MULTIAXIAL | In distribution |
| 2000-2125 | Device Size Text, specify—4.0MM DIA X 25MM STANDARD | In distribution |
| 14-592365 | Device Size Text, specify—5.5 HA MULTI SCREW 5.5 X 65MM | In distribution |
| 14-512340RE | In distribution | |
| 14-500325 | Device Size Text, specify—DIA 8.5MM X 35MM MULTIAXIAL | In distribution |
| 14-592550 | In distribution | |
| 2000-4785 | Device Size Text, specify—9.5 X 85MM FIXED SCREW | In distribution |
| 14-512125 | Device Size Text, specify—4.0MM X 25MM UNIPLANAR SCREW | In distribution |
| 2000-7465C | Device Size Text, specify—SCREW, 6.5MM X 65MM MULTIAXIAL | In distribution |
| 2000-5510 | Device Size Text, specify—LEFT ANGLED HOOK, MEDIUM | In distribution |
| 14-512565R | Device Size Text, specify—7.5MM X 65MM REDUCTION | In distribution |
| 2000-5112 | Device Size Text, specify—115MM TI ALLOY CURVED ROD | In distribution |
| 14-500581 | Device Size Text, specify—5.5MM DIA X 300MM | In distribution |
| 2000-4140 | Device Size Text, specify—4.0MM DIA. X 40MM FIXED SCREW | In distribution |
| 14-512550R | Device Size Text, specify—7.5MM X 50MM REDUCTION | In distribution |
| 2000-5090 | Device Size Text, specify—90MM CP TI CURVED ROD | In distribution |
| 14-512635 | Device Size Text, specify—8.5MM X 35MM UNIPLANAR SCREW | In distribution |
| 14-500853 | Device Size Text, specify—5.5MM X 6.35MM PARALLEL TI | In distribution |
| 14-500263 | Device Size Text, specify—DIA 5.5MM X 25MM MULTIAXIAL | In distribution |
| 2000-4450E | In distribution | |
| 2000-5514E | In distribution | |
| 14-578890 | Device Size Text, specify—5.5 TI 10.5 X 90MM TRANSLATION | In distribution |
| 2000-2120 | Device Size Text, specify—4.0MM DIA X 20MM STANDARD | In distribution |
| 2000-7275 | Device Size Text, specify—4.75X75MM MULTIAXIAL RED.SCREW | In distribution |
| 14-592535 | Device Size Text, specify—5.5 HA MULTI SCREW 7.5 X 35MM | In distribution |
| 2000-4340 | Device Size Text, specify—5.5 X 40MM FIXED SCREW | In distribution |
| 2000-4635E | In distribution | |
| 2000-7735C | Device Size Text, specify—SCREW, 9.5MM X 35MM MULTIAXIAL | In distribution |
| 2000-2145 | Device Size Text, specify—4.0MM DIA X 45MM STANDARD | In distribution |
| 14-500802 | Device Size Text, specify—3.5MM X 4.75MM PARALLEL TI | In distribution |
| 14-512665R | Device Size Text, specify—8.5MM X 65MM REDUCTION | In distribution |
| 2000-5170 | Device Size Text, specify—70MM TI ALLOY CURVED ROD | In distribution |
| 14-578670 | Device Size Text, specify—5.5 TI 8.5X70MM TRANSLATION | In distribution |
| 2000-2690 | Device Size Text, specify—8.5X90MM MULTIAXIAL SCREW | In distribution |
| 2000-5305E | In distribution | |
| 14-500348 | Device Size Text, specify—DIA 9.5MM X 50MM MULTIAXIAL | In distribution |
| 14-592680 | Device Size Text, specify—5.5 HA MULTI SCREW 8.5 X 80MM | In distribution |
| 14-500768 | Device Size Text, specify—6.0MM X 6.0MM AXIAL,TI | In distribution |
| 14-512620 | Device Size Text, specify—8.5MM X 20MM UNIPLANAR SCREW | In distribution |
| 14-512245E | In distribution | |
| 14-512665 | Device Size Text, specify—8.5MM X 65MM UNIPLANAR SCREW | In distribution |
| 2000-5080 | Device Size Text, specify—80MM CP TI CURVED ROD | In distribution |
| 14-500314E | In distribution | |
| 14-512670R | Device Size Text, specify—8.5MM X 70MM REDUCTION | In distribution |
| 2000-7455E | In distribution | |
| 14-500331 | Device Size Text, specify—DIA 8.5MM X 65MM MULTIAXIAL | In distribution |
| 14-500750 | Device Size Text, specify—3.5MM X 3.5MM AXIAL,TI | In distribution |
| 14-592585 | Device Size Text, specify—5.5 HA MULTI SCREW 7.5 X 85MM | In distribution |
| 2000-7450E | In distribution | |
| 2000-4695 | Device Size Text, specify—8.5 X 95MM FIXED SCREW | In distribution |
| 2000-5035 | Device Size Text, specify—35MM CP TI CURVED ROD | In distribution |
| 2000-7820C | Device Size Text, specify—SCREW,10.5MM X 20MM MULTIAXIAL | In distribution |
| 2000-7850C | Device Size Text, specify—SCREW,10.5MM X 50MM MULTIAXIAL | In distribution |
| 14-578680 | Device Size Text, specify—5.5 TI 8.5X80MM TRANSLATION | In distribution |
| 14-500272 | Device Size Text, specify—DIA 5.5MM X 70MM MULTIAXIAL | In distribution |
| 14-500767 | Device Size Text, specify—5.5MM X 6.35MM AXIAL,TI | In distribution |
| 14-578799 | Device Size Text, specify—5.5 TI 9.5 X 100MM TRANSLATION | In distribution |
| 14-592425 | Device Size Text, specify—5.5 HA MULTI SCREW 6.5 X 25MM | In distribution |
| 14-500289 | Device Size Text, specify—DIA 6.5MM X 55MM MULTIAXIAL | In distribution |
| 2000-5518 | Device Size Text, specify—WIDE LAMINAR HOOK, SMALL (6MM) | In distribution |
| 2000-4720 | Device Size Text, specify—9.5 X 20MM FIXED SCREW | In distribution |
| 14-578790 | Device Size Text, specify—5.5 TI 9.5 X 90MM TRANSLATION | In distribution |
| 2000-7651 | Device Size Text, specify—8.5MM X 50MM REDUCTION SCREW | In distribution |
| 2000-7335E | In distribution | |
| 14-578640 | Device Size Text, specify—5.5 TI 8.5X40MM TRANSLATION | In distribution |
| 2000-7446 | Device Size Text, specify—6.5MM X 45MM REDUCTION SCREW | In distribution |
| 14-500256 | Device Size Text, specify—DIA 4.75MM X 90MM MULTIAXIAL | In distribution |
| 2000-7555C | Device Size Text, specify—SCREW, 7.5MM X 55MM MULTIAXIAL | In distribution |
| 2000-7698 | Device Size Text, specify—8.5MM X 100MM REDUCTION SCREW | In distribution |
| 2000-4125 | Device Size Text, specify—4.0MM DIA. X 25MM FIXED SCREW | In distribution |
| 14-500817 | Device Size Text, specify—5.5MM X 6.35MM PARALLEL TI | In distribution |
| 2000-4230E | In distribution | |
| 2000-4625 | Device Size Text, specify—8.5 X 25MM FIXED SCREW | In distribution |
| 14-512235 | Device Size Text, specify—4.75MM X 35MM UNIPLANAR SCREW | In distribution |
| 2000-4685 | Device Size Text, specify—8.5 X 85MM FIXED SCREW | In distribution |
| 2000-7385 | Device Size Text, specify—5.5X85MM MULTIAXIAL RED.SCREW | In distribution |
| 2000-4330E | In distribution | |
| 2000-7691 | Device Size Text, specify—8.5MM X 90MM REDUCTION SCREW | In distribution |
| 2000-7870C | Device Size Text, specify—SCREW,10.5MM X 70MM MULTIAXIAL | In distribution |
| 14-512899R | Device Size Text, specify—10.5MM X 100MM REDUCTION | In distribution |
| 14-500575 | Device Size Text, specify—5.5MM DIA X 300MM | In distribution |
| 14-500804 | Device Size Text, specify—3.5MM X 6.0MM PARALLEL TI | In distribution |
| 14-512455 | Device Size Text, specify—6.5MM X 55MM UNIPLANAR SCREW | In distribution |
| 14-512565 | Device Size Text, specify—7.5MM X 65MM UNIPLAR SCREW | In distribution |
| 14-578402 | Device Size Text, specify—5.5 TI 6.5X110MM TRANSLATION | In distribution |
| 2000-2855 | Device Size Text, specify—10.5X55MM MULTIAXIAL SCREW | In distribution |
| 14-500308 | Device Size Text, specify—DIA 7.5MM X 50MM MULTIAXIAL | In distribution |
| 2000-2290 | Device Size Text, specify—4.75X90MM MULTIAXIAL SCREW | In distribution |
| 14-500770 | Device Size Text, specify—6.35MM X 6.35MM AXIAL,TI | In distribution |
| 14-500850 | Device Size Text, specify—4.75MM X 6.35MM PARALLEL TI | In distribution |
| 2000-7620 | Device Size Text, specify—8.5X20MM MULTIAXIAL RED.SCREW | In distribution |
| 2000-7781 | Device Size Text, specify—9.5MM X 80MM REDUCTION SCREW | In distribution |
| 14-500355 | Device Size Text, specify—DIA 9.5MM X 85MM MULTIAXIAL | In distribution |
| 14-500371 | Device Size Text, specify—DIA 10.5MM X 65MM MULTIAXIAL | In distribution |
| 14-512430R | Device Size Text, specify—6.5MM X 30MM REDUCTION | In distribution |
| 2000-5190E | In distribution | |
| 2000-4655E | In distribution | |
| 2000-7780C | Device Size Text, specify—SCREW, 9.5MM X 80MM MULTIAXIAL | In distribution |
| 14-500270 | Device Size Text, specify—DIA 5.5MM X 60MM MULTIAXIAL | In distribution |
| 2000-2635E | In distribution | |
| 14-512690 | Device Size Text, specify—8.5MM X 90MM UNIPLANAR SCREW | In distribution |
| 14-500290 | Device Size Text, specify—DIA 6.5MM X 60MM MULTIAXIAL | In distribution |
| 2000-2765 | Device Size Text, specify—9.5X65MM MULTIAXIAL SCREW | In distribution |
| 2000-4795 | Device Size Text, specify—9.5 X 95MM FIXED SCREW | In distribution |
| 14-512335RE | In distribution | |
| 2000-4155 | Device Size Text, specify—4.0MM DIA. X 55MM FIXED SCREW | In distribution |
| 2000-4240E | In distribution | |
| 2000-4899 | Device Size Text, specify—10.5 X 100MM FIXED SCREW | In distribution |
| 14-512335E | In distribution | |
| 14-592645 | In distribution | |
| 14-512770R | Device Size Text, specify—9.5MM X 70MM REDUCTION | In distribution |
| 14-592530 | Device Size Text, specify—5.5 HA MULTI SCREW 7.5 X 30MM | In distribution |
| 14-592660 | Device Size Text, specify—5.5 HA MULTI SCREW 8.5 X 60MM | In distribution |
| 2000-7330E | In distribution | |
| 14-592305 | Device Size Text, specify—5.5 HA MULTI SCREW 5.5 X125MM | In distribution |
| 2000-5566 | Device Size Text, specify—RIGHT TRANSVERSE PROCESS HOOK, | In distribution |
| 2000-5564 | Device Size Text, specify—LEFT TRANSVERSE PROCESS HOOK, | In distribution |
| 2000-4440E | In distribution | |
| 2000-7465 | Device Size Text, specify—6.5X65MM MULTIAXIAL RED.SCREW | In distribution |
| 14-578225 | Device Size Text, specify—5.5 TI 4.75X25MM TRANSLATION | In distribution |
| 2000-7635C | Device Size Text, specify—SCREW, 8.5MM X 35MM MULTIAXIAL | In distribution |
| 14-592408 | Device Size Text, specify—5.5 HA MULTI SCREW 6.5 X140MM | In distribution |
| 14-500841 | Device Size Text, specify—3.5MM X 6.35MM PARALLEL TI | In distribution |
| 14-592490 | Device Size Text, specify—5.5 HA MULTI SCREW 6.5 X 90MM | In distribution |
| 14-512680R | Device Size Text, specify—8.5MM X 80MM REDUCTION | In distribution |
| 14-512875R | Device Size Text, specify—10.5MM X 75MM REDUCTION | In distribution |
| 2000-2360 | Device Size Text, specify—5.5X60MM MULTIAXIAL SCREW | In distribution |
| 14-512785R | Device Size Text, specify—9.5MM X 85MM REDUCTION | In distribution |
| 14-500370 | Device Size Text, specify—DIA 10.5MM X 60MM MULTIAXIAL | In distribution |
| 14-512655 | Device Size Text, specify—8.5MM X 55MM UNIPLANAR SCREW | In distribution |
| 2000-2785 | Device Size Text, specify—9.5X85MM MULTIAXIAL SCREW | In distribution |
| 2000-5060 | Device Size Text, specify—60MM CP TI CURVED ROD | In distribution |
| 14-500372 | Device Size Text, specify—DIA 10.5MM X 70MM MULTIAXIAL | In distribution |
| 14-512590 | Device Size Text, specify—7.5MM X 90MM UNIPLANAR SCREW | In distribution |
| 2000-7255 | Device Size Text, specify—4.75X55MM MULTIAXIAL RED.SCREW | In distribution |
| 2000-2770 | Device Size Text, specify—9.5X70MM MULTIAXIAL SCREW | In distribution |
| 2000-4380 | Device Size Text, specify—5.5 X 80MM FIXED SCREW | In distribution |
| 14-500306 | Device Size Text, specify—DIA 7.5MM X 40MM MULTIAXIAL | In distribution |
| 2000-7650C | Device Size Text, specify—SCREW, 8.5MM X 50MM MULTIAXIAL | In distribution |
| 14-500266 | Device Size Text, specify—DIA 5.5MM X 40MM MULTIAXIAL | In distribution |
| 2000-2895 | Device Size Text, specify—10.5X95MM MULTIAXIAL SCREW | In distribution |
| 14-512230 | Device Size Text, specify—4.75MM X 30MM UNIPLANAR SCREW | In distribution |
| 14-592590 | Device Size Text, specify—5.5 HA MULTI SCREW 7.5 X 90MM | In distribution |
| 2000-5405E | In distribution | |
| 14-512855R | Device Size Text, specify—10.5MM X 55MM REDUCTION | In distribution |
| 2000-2899 | Device Size Text, specify—10.5X100MM MULTIAXIAL SCREW | In distribution |
| 2000-7761 | Device Size Text, specify—9.5MM X 60MM REDUCTION SCREW | In distribution |
| 2000-7551 | Device Size Text, specify—7.5MM X 50MM REDUCTION SCREW | In distribution |
| 14-500375 | Device Size Text, specify—DIA 10.5MM X 85MM MULTIAXIAL | 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 |
|---|---|
| K253093 | 2025-12-17 |
Recalls
4 of these are 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 |
|---|---|---|---|---|---|
| 2023-10-16 | Class II | Nonconforming Material/Component | Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size description of 7.5 x 40; use of incorrect screws could lead to screw perforation and indent | 3 | |
| 2018-07-30 | Class II | Nonconforming Material/Component | The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications | 16,429 devices (Thoracolumbosacral pedicle screw system,Spin | 2021-04-28 |
| 2012-11-30 | Class II | Process control | Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification | 1999 | 2015-05-22 |
| 2011-12-19 | Class II | Device Design | The Telluride Percutaneous Rod Inserter Long does not contain a feature that locks the Rod in place during use. There is a potential for the Rod to disengage from the Inserter during insertion, and could lead to harm to the patient. | 10 | 2015-03-23 |
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.