Polaris™ 6.35 Spinal System

217 catalogue numbers from 50-6594MP, listed by Biomet Spine, United States, under Orthosis, Spinal Pedicle Fixation. 13 manufacturers in China are registered for this product code.

Registry build 21.09.26
13manufacturers in China registered for this device type
217catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code MNI
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
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
Suzhou Kangli Orthopaedics Instrument Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 11
Changzhou Yonghua Medical Instruments Co., Ltd. Changzhou Jiangsu Manufacturer 8
Jiangsu Ideal Medical Science & Technology Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 7

Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spinal Pedicle Fixation

Record

Regulatory record for Polaris™ 6.35 Spinal System
Listed by Biomet Spine, United States
FDA product code MNI
Device type Orthosis, Spinal Pedicle Fixation
Device class Class 2
Regulation 21 CFR 888.3070
Record published 2020-06-26
Record revised 2025-07-02 (version 7)

Specifications

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 numbers for Polaris™ 6.35 Spinal System
Catalogue number Size Status
50-6594MP TI VARIABLE LOCKING SCREW 5.0 X 40MM HF SEAT ASSY In distribution
14-574545 7.5MM(D) X 45MM FIXED SCREW In distribution
14-513760R 9.5MM X 60MM REDUCTION UNIPLANAR SCREW In distribution
14-574440C 6.5MM(D) X 40MM SST CANNULATED FIXED SCREW In distribution
14-515399 6.35 TI 5.5X100MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-573255 4.75 X 55MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-573780 9.5 X 80MM MULTIAXIAL ILIAC In distribution
14-575404 510MM ROD, HARD, 6.35 SST In distribution
14-513185 4.0MM X 85MM UNIPLANAR SCREW In distribution
14-574330C 5.5MM(D) X 30MM SST CANNULATED FIXED SCREW In distribution
14-513625 8.5MM X 25MM UNIPLANAR SCREW In distribution
14-515755 6.35 TI 9.5X55MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-513599 7.5MM X 100MM UNIPLANAR SCREW In distribution
14-575418 60CM BE ROD, STANDARD, 6.35SST In distribution
50-6807MP MULTI-AXIAL SCREW 4.75MM (D) X 40MM (L) In distribution
14-573280 4.75 X 80MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-513485R 6.5MM X 85MM REDUCTION UNIPLANAR SCREW In distribution
14-575169 ANGULATING CROSS CONNECTOR,XS In distribution
14-575514 LARGE: LEFT ANGLED HOOK In distribution
14-575155 20MM FIXED CROSS CONNECTOR In distribution
14-515460 6.35 TI 6.5X60MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-573430 6.5 X 30MM MULTIAXIAL ILIAC In distribution
14-575414 280MM ROD, HARD, 6.35 SST In distribution
14-573650 8.5 X 50MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-515365 6.35 TI 5.5X65MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-513735 9.5MM X 35MM UNIPLANAR SCREW In distribution
5500123-25 6.35MM DOUBLE B.E. ROD, SS ANNEALED, 25CM LENGTH In distribution
14-515465 6.35 TI 6.5X65MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-513840 10.5MM X 40MM UNIPLANAR SCREW In distribution
14-573880 10.5 X 80MM MULTIAXIAL ILIAC In distribution
14-513570R 7.5MM X 70MM REDUCTION UNIPLANAR SCREW In distribution
14-572330 5.5 X 30MM MULTIAXIAL SCREW In distribution
14-575403 610MM ROD, MEDIUM, W/HEX, SST In distribution
14-572320 5.5 X 20MM MULTIAXIAL SCREW In distribution
14-513780 9.5MM X 80MM UNIPLANAR SCREW In distribution
14-573320 5.5 X 20MM MULTIAXIAL ILIAC In distribution
14-573840 10.5 X 40MM MULTIAXIAL ILIAC In distribution
14-515685 6.35 TI 8.5X85MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-575552 LARGE: ANGLED BLADE HOOK In distribution
14-513699R 8.5MM X 100MM REDUCTION UNIPLANAR SCREW In distribution
14-573820 10.5 X 20MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-515445 6.35 TI 6.5X45MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-572550C 7.5MM(D) X 50MM SST CANNULATED MULTI-AXIAL SCREW In distribution
14-573160 4.0 X 60MM MULTIAXIAL ILIAC In distribution
14-573280 4.75 X 80MM MULTIAXIAL ILIAC In distribution
14-573895 10.5 X 95MM MULTIAXIAL ILIAC In distribution
14-515470 6.35 TI 6.5X70MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-573455 6.5 X 55MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-515740 6.35 TI 9.5X40MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-573155 4.0 X 55MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-513775 9.5MM X 75MM UNIPLANAR SCREW In distribution
14-577330 5.5MM(D) X 30MM SST MULTIAXIAL REDUCTION SCREW In distribution
14-513465 6.5MM X 65MM UNIPLANAR SCREW In distribution
50-6552MP MULTI-AXIAL SCREW 4.0MM (D) X 30MM (L) In distribution
14-515270 6.35 TI 4.75X70MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-501295 6.5MM(D) X 85MM(L) MULTIAXIAL ILIAC SCREW (6.35) In distribution
14-513265 4.75MM X 65MM UNIPLANAR SCREW In distribution
5500120-09 6.35MM SINGLE B.E. ROD, CPTI 9CM LENGTH In distribution
14-513185R 4.0MM X 85MM REDUCTION UNIPLANAR SCREW In distribution
14-513535R 7.5MM X 35MM REDUCTION UNIPLANAR SCREW In distribution
14-572545 7.5 X 45MM MULTIAXIAL SCREW In distribution
14-573540 7.5 X 40MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-575142 12MM FIXED CROSS CONNECTOR In distribution
14-575548 SMALL: ANGLED BLADE HOOK In distribution
14-515835 6.35 TI 10.5X35MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-515860 6.35 TI 10.5X60MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-573530 7.5 X 30MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-574120 4.0MM(D) X 20MM FIXED SCREW In distribution
14-575506 SMALL: LEFT ANGLED HOOK In distribution
14-573640 8.5 X 40MM MULTIAXIAL ILIAC In distribution
14-515340 6.35 TI 5.5X40MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-573190 4.0 X 90MM MULTIAXIAL ILIAC In distribution
14-513660 8.5MM X 60MM UNIPLANAR SCREW In distribution
14-513845 10.5MM X 45MM UNIPLANAR SCREW In distribution
14-572655 8.5 X 55MM MULTIAXIAL SCREW In distribution
14-573550 7.5 X 50MM MULTIAXIAL ILIAC In distribution
14-573285 4.75 X 85MM MULTIAXIAL ILIAC In distribution
14-575407 610MM ROD, HARD, W/HEX, SST In distribution
14-573745 9.5 X 45MM MULTIAXIAL ILIAC In distribution
14-574125 4.0MM(D) X 25MM FIXED SCREW In distribution
14-513375 5.5MM X 75MM UNIPLANAR SCREW In distribution
14-573735 9.5 X 35MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-513599R 7.5MM X 100MM REDUCTION UNIPLANAR SCREW In distribution
14-513260R 4.75MM X 60MM REDUCTION UNIPLANAR SCREW In distribution
14-575153 16MM FIXED CROSS CONNECTOR In distribution
14-575416 280MM ROD, EXTRA HARD, 6.35 In distribution
14-575560 SMALL LEFT TP HOOK 6.35 SST In distribution
14-573655 8.5 X 55MM MULTIAXIAL ILIAC In distribution
14-575411 610MM ROD, X-HARD, W/HEX, SST In distribution
14-515335 6.35 TI 5.5X35MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-515690 6.35 TI 8.5X90MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-572120 4.0 X 20MM MULTIAXIAL SCREW In distribution
14-575566 MEDIUM RIGHT TP HOOK 6.35 SST In distribution
14-577455 6.5MM(D) X 55MM SST MULTIAXIAL REDUCTION SCREW In distribution
14-515540 6.35 TI 7.5X40MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-573340 5.5 X 40MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-572540 7.5 X 40MM MULTIAXIAL SCREW In distribution
14-574435 6.5MM(D) X 35 FIXED SCREW In distribution
50-6591MP TI VARIABLE LOCKING SCREW 5.0 X 25MM HF SEAT ASSY In distribution
14-513565R 7.5MM X 65MM REDUCTION UNIPLANAR SCREW In distribution
14-573170 4.0 X 70MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-573470 6.5 X 70MM MULTIAXIAL ILIAC SCREW In distribution
14-574325 5.5MM(D) X 25MM FIXED SCREW In distribution
14-513645R 8.5MM X 45MM REDUCTION UNIPLANAR SCREW In distribution
14-573855 10.5 X 55MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-573285 4.75 X 85MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-513645 8.5MM X 45MM UNIPLANAR SCREW In distribution
14-573585 7.5 X 85MM MULTIAXIAL ILIAC In distribution
14-575412 280MM ROD, MEDIUM, 6.35 SST In distribution
50-6593MP TI VARIABLE LOCKING SCREW 5.0 X 35MM HF SEAT ASSY In distribution
14-515555 6.35 TI 7.5X55MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-501298 6.5MM(D) X 100MM(L) MULTIAXIAL In distribution
14-573685 8.5 X 85MM MULTIAXIAL ILIAC In distribution
14-575172 ANGULATING CROSS CONNECTOR,L In distribution
14-513635 8.5MM X 35MM UNIPLANAR SCREW In distribution
14-575402 510MM ROD, MEDIUM, W/HEX, SST In distribution
14-513525 7.5MM X 25MM UNIPLANAR SCREW In distribution
14-572440C 6.5MM(D) X 40MM SST CANNULATED MULTI-AXIAL SCREW In distribution
14-513285 4.75MM X 85MM UNIPLANAR SCREW In distribution
14-515265 6.35 TI 4.75X65MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-574635 8.5MM(D) X 35MM FIXED SCREW In distribution
14-573890 10.5 X 90MM MULTIAXIAL ILIAC In distribution
14-515595 6.35 TI 7.5X95MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-573599 7.5 X 100MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-513450 6.5MM X 50MM UNIPLANAR SCREW In distribution
14-575554 SMALL: EXTENDED LAMINAR HOOK In distribution
14-513175R 4.0MM X 75MM REDUCTION UNIPLANAR SCREW In distribution
14-573165 4.0 X 65MM MULTIAXIAL ILIAC In distribution
14-577340 5.5MM(D) X 40MM SST MULTIAXIAL REDUCTION SCREW In distribution
14-513725R 9.5MM X 25MM REDUCTION UNIPLANAR SCREW In distribution
5500123-20 6.35MM DOUBLE B.E. ROD, SS ANNEALED, 20CM LENGTH In distribution
14-513145R 4.0MM X 45MM REDUCTION UNIPLANAR SCREW In distribution
5500122-09 6.35MM SINGLE B.E. ROD, SS ANNEALED, 9CM LENGTH In distribution
5500123-60 6.35MM DOUBLE B.E. ROD, SS ANNEALED, 60CM LENGTH In distribution
14-511635 8.5MM X 35MM MULTI-AXIAL SCREW In distribution
14-573565 7.5 X 65MM MULTIAXIAL ILIAC In distribution
14-573720 9.5 X 20MM MULTIAXIAL ILIAC In distribution
14-515675 6.35 TI 8.5X75MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-573399 5.5 X 100MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-573355 5.5 X 55MM MULTIAXIAL ILIAC In distribution
14-575504 PEDICLE HOOK, LARGE In distribution
14-513299 4.75MM X 100MM UNIPLANAR SCREW In distribution
14-513399 5.5MM X 100MM UNIPLANAR SCREW In distribution
14-573230 4.75 X 30MM MULTIAXIAL ILIAC In distribution
14-511535 7.5MM X 35MM MULTI-AXIAL SCREW In distribution
50-6805MP MULTI-AXIAL SCREW 4.75MM (D) X 30MM (L) In distribution
14-573420 6.5 X 20MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-515655 6.35 TI 8.5X55MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-573650 8.5 X 50MM MULTIAXIAL ILIAC In distribution
14-573870 10.5 X 70MM MULTIAXIAL ILIAC SCREW, SST In distribution
5500120-06 6.35MM SINGLE B.E. ROD, CPTI 6CM LENGTH In distribution
14-575401 610MM ROD, MEDIUM, 6.35 SST In distribution
14-513350 5.5MM X 50MM UNIPLANAR SCREW In distribution
14-513685R 8.5MM X 85MM REDUCTION UNIPLANAR SCREW In distribution
14-573645 8.5 X 45MM MULTIAXIAL ILIAC In distribution
14-513675 8.5MM X 75MM UNIPLANAR SCREW In distribution
14-573185 4.0 X 85MM MULTIAXIAL ILIAC In distribution
14-574240 4.75MM(D) X 40MM FIXED SCREW In distribution
14-513125 4.0MM X 25MM UNIPLANAR SCREW In distribution
14-513430 6.5MM X 30MM UNIPLANAR SCREW In distribution
14-513720 9.5MM X 20MM UNIPLANAR SCREW In distribution
14-575510 MEDIUM: LEFT ANGLED HOOK In distribution
14-513490 6.5MM X 90MM UNIPLANAR SCREW In distribution
14-513730R 9.5MM X 30MM REDUCTION UNIPLANAR SCREW In distribution
14-513495 6.5MM X 95MM UNIPLANAR SCREW In distribution
14-573125 4.0 X 25MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-515845 6.35 TI 10.5X45MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-573220 4.75 X 20MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-573375 5.5 X 75MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-515280 6.35 TI 4.75X80MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-515735 6.35 TI 9.5X35MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
50-6807MP 4.75MM (D) X 40MM (L) In distribution
14-515395 6.35 TI 5.5X95MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
6586MP VLS SCREW W/FLUTES-6.35 In distribution
14-574355C 5.5MM(D) X 55MM SST CANNULATED FIXED SCREW In distribution
14-513545 7.5MM X 45MM UNIPLANAR SCREW In distribution
14-573799 9.5 X 100MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-515620 6.35 TI 8.5X20MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-575410 510MM ROD, X-HARD, W/HEX, SST In distribution
14-513480R 6.5MM X 80MM REDUCTION UNIPLANAR SCREW In distribution
14-515550 6.35 TI 7.5X50MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-573275 4.75 X 75MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-513595 7.5MM X 95MM UNIPLANAR SCREW In distribution
50-6803MP 4.75MM (D) X 20MM (L) In distribution
14-575417 280MM SST X-HARD, ROD W/HEX In distribution
14-515360 6.35 TI 5.5X60MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-577555 7.5MM(D) X 55MM SST MULTIAXIAL REDUCTION SCREW In distribution
14-513750 9.5MM X 50MM UNIPLANAR SCREW In distribution
14-515680 6.35 TI 8.5X80MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-572440 6.5 X 40MM MULTIAXIAL SCREW In distribution
50-6551MP MULTI-AXIAL SCREW 4.0MM (D) X 25MM (L) In distribution
50-6553MP 4.0MM (D) X 35MM (L) In distribution
14-573355 5.5 X 55MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-513550R 7.5MM X 50MM REDUCTION UNIPLANAR SCREW In distribution
14-573590 7.5 X 90MM MULTIAXIAL ILIAC SCREW In distribution
14-501295 6.5MM(D) X 85MM(L) MULTIAXIAL In distribution
14-572225 4.75 X 25MM MULTIAXIAL SCREW In distribution
14-573555 7.5 X 55MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-513370 5.5MM X 70MM UNIPLANAR SCREW In distribution
14-573195 4.0 X 95MM MULTIAXIAL ILIAC In distribution
14-513385R 5.5MM X 85MM REDUCTION UNIPLANAR SCREW In distribution
14-575401 610MM ROD, MEDIUM, 6.35 SST In distribution
14-513765R 9.5MM X 65MM REDUCTION UNIPLANAR SCREW In distribution
50-6554MP 4.0MM (D) X 40MM (L) In distribution
14-572245 4.75 X 45MM MULTIAXIAL SCREW In distribution
14-513560 7.5MM X 60MM UNIPLANAR SCREW In distribution
14-573790 9.5 X 90MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-513499 6.5MM X 100MM UNIPLANAR SCREW In distribution
14-515650 6.35 TI 8.5X50MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-515320 6.35 TI 5.5X20MM MAS REDUC MULTIAXIAL REDUCTION SCREW In distribution
14-573165 4.0 X 65MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-573460 6.5 X 60MM MULTIAXIAL ILIAC SCREW In distribution
14-575157 24MM FIXED CROSS CONNECTOR In distribution
14-513885 10.5MM X 85MM UNIPLANAR SCREW In distribution
50-6592MP 5.0 X 30MM HF SEAT ASSY In distribution
14-573750 9.5 X 50MM MULTIAXIAL ILIAC In distribution
50-6806MP 4.75MM (D) X 35MM (L) In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
CD Horizon® Spinal System Medtronic Sofamor Danek, Inc. 2,342
Creo Globus Medical, Inc. 1,784
ReLine Nuvasive, Inc. 1,718
AnyPlus Spinal Fixation System GS Medical Co., Ltd. 1,525
Apex Spine System Spinecraft LLC 1,114
Revere Globus Medical, Inc. 1,051
LnK Spinal Fixation System L&K Biomed Co., Ltd. 974
LnK Basic Spinal Fixation System L&K Biomed Co., Ltd. 935
Arsenal Alphatec Spine, Inc. 932
Zavation Zavation 864
Polaris™ 5.5 Spinal System Biomet Spine 809
Apex-DL Spine System Spinecraft LLC 792

Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer