Polaris 5.5 Spinal System

707 catalogue numbers from 2000-2335E, listed by Biomet Spine, United States, under Orthosis, Spondylolisthesis Spinal Fixation. 13 manufacturers in China are registered for this product code.

Registry build 21.09.26
13manufacturers in China registered for this device type
707catalogue 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 MNH
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, Spondylolisthesis Spinal Fixation

Record

Regulatory record for Polaris 5.5 Spinal System
Listed by Biomet Spine, United States
FDA product code MNH
Device type Orthosis, Spondylolisthesis Spinal Fixation
Device class Class 2
Regulation 21 CFR 888.3070
Record published 2015-10-24
Record revised 2025-07-02 (version 7)

Specifications

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 numbers for Polaris 5.5 Spinal System
Catalogue number Size Status
2000-2335E 5.5 X 35MM MULTIAXIAL SCREW In distribution
14-506185R 4.0MM X 85MM REDUCTION UNIPLANAR SCREW In distribution
14-503380 5.5 X 80MM MULTIAXIAL ILIAC In distribution
2000-2680 8.5X80MM MULTIAXIAL SCREW In distribution
2000-5548 ANGLED BLADE HOOK, SMALL (6MM) In distribution
14-503235 4.75 X 35MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-512245R 4.75MM X 45MM REDUCTION UNIPLANAR SCREW In distribution
14-578535R 5.5 TI 7.5X35MM TRANS REDUC TRANSLATION REDUCTION SCREW In distribution
14-512890R 10.5MM X 90MM REDUCTION UNIPLANAR SCREW In distribution
14-500315 DIA 7.5MM X 85MM MULTIAXIAL ILIAC SCREW 5.5 In distribution
2000-7436 6.5MM X 35MM REDUCTION SCREW In distribution
2000-7630 8.5X30MM MULTIAXIAL RED.SCREW In distribution
14-510760 5.5 TI 7.5 X 60MM TAPERED MAS TAPERED MULTIAXIAL SCREW In distribution
14-505552 ANGLED BLADE HOOK-5.5 SST LARGE In distribution
14-500264 DIA 5.5MM X 30MM MULTIAXIAL ILIAC SCREW 5.5 In distribution
14-503230 4.75 X 30MM MULTIAXIAL ILIAC SCREW, SST In distribution
2000-7355 5.5X55MM MULTIAXIAL RED.SCREW In distribution
14-504240 4.75MM X 40MM FIXED SCREW 5.5 SST In distribution
2000-2175 4.0MM DIA X 75MM STANDARD In distribution
2000-4530E 7.5 X 30MM FIXED SCREW In distribution
14-506465R 6.5MM X 65MM REDUCTION UNIPLANAR SCREW In distribution
14-578335 5.5 TI 5.5X35MM TRANSLATION TRANSLATION SCREW In distribution
2000-7898 10.5MM X 100MM REDUCTION SCREW In distribution
14-512455E 6.5 mm x 55 mm Uniplanar Screw In distribution
14-503175 4.0 X 75MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-512640R 8.5MM X 40MM REDUCTION In distribution
2000-5013 120MM CP TI CURVED ROD In distribution
2000-5012 115MM CP TI CURVED ROD In distribution
14-500364 DIA 10.5MM X 30MM MULTIAXIAL ILIAC SCREW 5.5 In distribution
2000-2745 9.5X45MM MULTIAXIAL SCREW In distribution
14-502440 6.5 X 40MM MULTIAXIAL SCREW 5.5 SST In distribution
14-512265 4.75MM X 65MM UNIPLANAR SCREW In distribution
14-505110 DEROTATION PLUG, 5.5 SST In distribution
14-503360 5.5 X 60MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-578825 5.5 TI 10.5 X 25MM TRANSLATION TRANSLATION SCREW In distribution
2000-2799 9.5X100MM MULTIAXIAL SCREW In distribution
2000-7720 9.5X20MM MULTIAXIAL RED.SCREW In distribution
14-503770 9.5 X 70MM MULTIAXIAL ILIAC In distribution
14-512535R 7.5MM X 35MM REDUCTION In distribution
2000-5095 95MM CP TI CURVED ROD In distribution
2000-7730 9.5X30MM MULTIAXIAL RED.SCREW In distribution
2000-7335E 5.5 x 35 mm Multiaxial Red.Screw In distribution
2000-5050 50MM CP TI CURVED ROD In distribution
14-505500 PEDICLE HOOK -5.5 SST (SMALL) In distribution
2000-4325 5.5 X 25MM FIXED SCREW In distribution
2000-7886 10.5MM X 85MM REDUCTION SCREW In distribution
14-512790R 9.5MM X 90MM REDUCTION UNIPLANAR SCREW In distribution
14-504550 7.5MM X 50MM FIXED SCREW 5.5 In distribution
2000-5014 125MM CP TI CURVED ROD In distribution
14-512180R 4.0MM X 80MM REDUCTION In distribution
14-505526 NARROW LAMINAR HOOK-5.5 SST In distribution
2000-1020E Lateral Connector, Open, 25 mm In distribution
94488 18MM FIXED CROSS CONNECTOR In distribution
14-578425 5.5 TI 6.5X25MM TRANSLATION TRANSLATION SCREW In distribution
2000-7660 8.5X60MM MULTIAXIAL RED.SCREW In distribution
2000-7885C SCREW,10.5MM X 85MM MULTIAXIAL CANNULATED REDUCTION In distribution
14-578575R 5.5 TI 7.5X75MM TRANS REDUC TRANSLATION REDUCTION SCREW In distribution
14-500314E 7.5 mm ø x 80 mm Multiaxial Iliac Screw In distribution
2000-4755 9.5 X 55MM FIXED SCREW In distribution
14-512299 4.75MM X 100MM UNIPLANAR SCREW In distribution
2000-7825C SCREW,10.5MM X 25MM MULTIAXIAL CANNULATED REDUCTION In distribution
2000-7425C SCREW, 6.5MM X 25MM MULTIAXIAL In distribution
2000-5518E Wide Laminar Hook, Small (6 mm) In distribution
14-500283 DIA 6.5MM X 25MM MULTIAXIAL ILIAC SCREW 5.5 In distribution
2000-4155 4.0MM DIA. X 55MM FIXED SCREW In distribution
2000-4540E 7.5 X 40MM FIXED SCREW In distribution
2000-7281 4.75MM X 80MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD In distribution
2000-7340C SCREW, 5.5MM X 40MM MULTIAXIAL In distribution
14-578560R 5.5 TI 7.5X60MM TRANS REDUC TRANSLATION REDUCTION SCREW In distribution
2000-2465 6.5X65MM MULTIAXIAL SCREW In distribution
2000-7721 9.5MM X 20MM REDUCTION SCREW In distribution
2000-7690C SCREW, 8.5MM X 90MM MULTIAXIAL In distribution
14-504145 4.0MM X 45MM FIXED SCREW 5.5 SST In distribution
2000-5175 75MM TI ALLOY CURVED ROD In distribution
2000-4355 5.5 X 55MM FIXED SCREW In distribution
14-504855 10.5MM X 55MM FIXED SCREW 5.5 In distribution
2000-1022E LATERAL CONNECTOR, OPEN, 50MM In distribution
2000-7781 9.5MM X 80MM REDUCTION SCREW In distribution
2000-7351 5.5MM X 50MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD In distribution
2000-5480 80MM TI ALLOY CURVED ROD W/HEX In distribution
14-500264 DIA 5.5MM X 30MM MULTIAXIAL In distribution
2000-5544E Left Offset Hook, Large (9 mm) In distribution
14-504590 7.5MM X 90MM FIXED SCREW 5.5 SST In distribution
14-512135E 4.0 mm x 35 mm Uniplanar Screw In distribution
14-512750R 9.5MM X 50MM REDUCTION In distribution
14-503365 5.5 X 65MM MULTIAXIAL ILIAC In distribution
14-512430E 6.5MM X 30MM UNIPLANAR SCREW In distribution
14-500601 5.5MM DIA X 600MM HARD PREBENT COCR ALLOY ROD In distribution
14-504375 5.5MM X 75MM FIXED SCREW 5.5 In distribution
2000-2160 4.0MM DIA X 60MM STANDARD In distribution
2000-7480 6.5X80MM MULTIAXIAL RED.SCREW In distribution
2000-5413 120MM TI ALLOY CURVED ROD WITH HEX In distribution
14-504485 6.5MM X 85MM FIXED SCREW 5.5 In distribution
14-510300 300MM 5.5 TI ALLOY ROD W/HEX In distribution
2000-7530E 7.5 x 30 mm Multiaxial Red.Screw In distribution
5006753 CROSS CONNECTOR, MEDIUM In distribution
14-503575 7.5 X 75MM MULTIAXIAL ILIAC In distribution
14-512770R 9.5MM X 70MM REDUCTION In distribution
2000-5315 130MM CP TI CURVED ROD In distribution
2000-2650E 8.5 X 50MM MULTIAXIAL SCREW In distribution
2000-2885 10.5X85MM MULTIAXIAL SCREW In distribution
2000-7351 5.5MM X 50MM REDUCTION SCREW In distribution
14-504875 10.5MM X 75MM FIXED SCREW 5.5 SST In distribution
2000-7796 9.5MM X 95MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD In distribution
14-504690 8.5MM X 90MM FIXED SCREW 5.5 In distribution
14-500296 DIA 6.5MM X 90MM MULTIAXIAL In distribution
2000-4435E 6.5 x 35 mm Fixed Screw In distribution
14-500291 DIA 6.5MM X 65MM MULTIAXIAL ILIAC SCREW 5.5 In distribution
2000-2340E 5.5 X 40MM MULTIAXIAL SCREW In distribution
14-578730R 5.5 TI 9.5X30MM TRANS REDUC TRANSLATION REDUCTION SCREW In distribution
2000-7675C SCREW, 8.5MM X 75MM MULTIAXIAL In distribution
5006762 20MM FIXED CROSS CONNECTOR In distribution
2000-4430E 6.5 X 30MM FIXED SCREW In distribution
14-578740R 5.5 TI 9.5X40MM TRANS REDUC TRANSLATION REDUCTION SCREW In distribution
14-500336E 8.5 mm ø x 90 mm Multiaxial Iliac Screw In distribution
2000-5065 65MM CP TI CURVED ROD In distribution
14-578480 5.5 TI 6.5X80MM TRANSLATION TRANSLATION SCREW In distribution
2000-7585 7.5X85MM MULTIAXIAL RED.SCREW In distribution
2000-4380 5.5 X 80MM FIXED SCREW In distribution
14-578245R 5.5 TI 4.75X45MM TRANS REDUC TRANSLATION REDUCTION SCREW In distribution
14-504380 5.5MM X 80MM FIXED SCREW 5.5 In distribution
14-500334 DIA 8.5MM X 80MM MULTIAXIAL In distribution
2000-7645C SCREW, 8.5MM X 45MM MULTIAXIAL CANNULATED REDUCTION In distribution
14-512899 10.5MM X 100MM UNIPLANAR SCREW In distribution
14-512680 8.5MM X 80MM UNIPLANAR SCREW In distribution
2000-2240 4.75X40MM MULTIAXIAL SCREW In distribution
2000-2135E 4.0MM DIA. X 35MM STANDARD In distribution
14-505542 RIGHT OFFSET HOOK-5.5 SST In distribution
2000-5528E NARROW LAMINAR HOOK, LARGE In distribution
2000-7499C SCREW,6.5MM X 100MM MULTIAXIAL In distribution
14-512395 5.5MM X 95MM UNIPLANAR SCREW In distribution
14-512435E 6.5 mm x 35 mm Uniplanar Screw In distribution
14-505401 610MM ROD, MEDIUM, SST In distribution
2000-5552E ANGLED BLADE HOOK, LARGE (9MM) In distribution
2000-5305 510MM CP TI ROD W/HEX In distribution
2000-7295 4.75X95MM MULTIAXIAL RED.SCREW In distribution
14-504860 10.5MM X 60MM FIXED SCREW 5.5 SST In distribution
2000-5015 130MM CP TI CURVED ROD In distribution
2000-7290 4.75X90MM MULTIAXIAL RED.SCREW In distribution
14-512820R 10.5MM X 20MM REDUCTION In distribution
2000-2270 4.75X70MM MULTIAXIAL SCREW In distribution
14-512355R 5.5MM X 55MM REDUCTION UNIPLANAR SCREW In distribution
14-578709R 5.5 TI 9.5X145MM TRANS REDUC TRANSLATION REDUCTION SCREW In distribution
2000-2440 6.5X40MM MULTIAXIAL SCREW In distribution
14-578504R 5.5 TI 7.5X120MM TRANS REDUC TRANSLATION REDUCTION SCREW In distribution
14-503399 5.5 X 100MM MULTIAXIAL ILIAC In distribution
14-503655 8.5 X 55MM MULTIAXIAL ILIAC In distribution
2000-2695 8.5X95MM MULTIAXIAL SCREW In distribution
2000-7555C SCREW, 7.5MM X 55MM MULTIAXIAL In distribution
14-578645R 5.5 TI 8.5X45MM TRANS REDUC TRANSLATION REDUCTION SCREW In distribution
2000-7345E 5.5X45MM MULTIAXIAL RED.SCREW In distribution
2000-7545C SCREW, 7.5MM X 45MM MULTIAXIAL In distribution
14-504675 8.5MM X 75MM FIXED SCREW 5.5 SST In distribution
14-504340 5.5MM X 40MM FIXED SCREW 5.5 In distribution
2000-5365 65MM CP TI CURVED ROD In distribution
2000-4445E 6.5 x 45 mm Fixed Screw In distribution
2000-7476 6.5MM X 75MM REDUCTION SCREW In distribution
14-578570 5.5 TI 7.5X70MM TRANSLATION TRANSLATION SCREW In distribution
14-512695R 8.5MM X 95MM REDUCTION In distribution
14-504720 9.5MM X 20MM FIXED SCREW 5.5 SST In distribution
2000-5556E Extended Laminar Hook, Medium (7.5 mm) In distribution
14-503550 7.5 X 50MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-578880 5.5 TI 10.5 X 80MM TRANSLATION TRANSLATION SCREW In distribution
14-503535 7.5 X 35MM MULTIAXIAL ILIAC SCREW, SST In distribution
2000-7731 9.5MM X 30MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD In distribution
14-503155 4.0 X 55MM MULTIAXIAL ILIAC SCREW, SST In distribution
2000-4520 7.5 X 20MM FIXED SCREW In distribution
2000-4390 5.5 X 90MM FIXED SCREW In distribution
14-512220R 4.75MM X 20MM REDUCTION UNIPLANAR SCREW In distribution
14-506220R 4.75MM X 20MM REDUCTION UNIPLANAR SCREW In distribution
14-503265 4.75 X 65MM MULTIAXIAL ILIAC In distribution
2000-5360 60MM CP TI CURVED ROD In distribution
2000-5528E Narrow Laminar Hook, Large (9 mm) In distribution
2000-7450E 6.5X50MM MULTIAXIAL RED.SCREW In distribution
14-507340 5.5 X 40MM MULTIAXIAL REDUCTION SCREW, 5.5 SST In distribution
2000-5504 PEDICLE HOOK, LARGE (9MM) In distribution
14-500131 14MM FIXED CROSS CONNECTOR In distribution
14-578775R 5.5 TI 9.5X75MM TRANS REDUC TRANSLATION REDUCTION SCREW In distribution
2000-2565 7.5X65MM MULTIAXIAL SCREW In distribution
14-512735R 9.5MM X 35MM REDUCTION UNIPLANAR SCREW In distribution
14-500247 DIA 4.75MM X 45MM MULTIAXIAL In distribution
2000-2335 5.5X35MM MULTIAXIAL SCREW In distribution
14-512525 7.5MM X 25MM UNIPLANAR SCREW In distribution
14-510735 5.5 TI 7.5 X 35MM TAPERED MAS TAPERED MULTIAXIAL SCREW In distribution
14-500590 5.5MM DIA X 300MM HIGH HEX COCR ALLOY ROD In distribution
14-504635 8.5MM X 35MM FIXED SCREW 5.5 SST In distribution
2000-4590 7.5 X 90MM FIXED SCREW In distribution
2000-4640E 8.5 x 40 mm Fixed Screw In distribution
14-512185R 4.0MM X 85MM REDUCTION UNIPLANAR SCREW In distribution
14-504499 6.5MM X 100MM FIXED SCREW 5.5 In distribution
2000-7291 4.75MM X 90MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD In distribution
5006753E CROSS CONNECTOR, MEDIUM In distribution
14-512699 8.5MM X 100MM UNIPLANAR SCREW In distribution
2000-4350E 5.5 X 50MM FIXED SCREW In distribution
14-506840R 10.5MM X 40MM REDUCTION UNIPLANAR SCREW In distribution
14-512485 6.5MM X 85MM UNIPLANAR SCREW In distribution
14-503680 8.5 X 80MM MULTIAXIAL ILIAC In distribution
2000-5375 75MM CP TI CURVED ROD W/ HEX In distribution
5006753E Cross Connector, Medium In distribution
2000-7775 9.5X75MM MULTIAXIAL RED.SCREW In distribution
2000-4385 5.5 X 85MM FIXED SCREW In distribution
14-512895 10.5MM X 95MM UNIPLANAR SCREW In distribution
14-578795R 5.5 TI 9.5X95MM TRANS REDUC TRANSLATION REDUCTION SCREW In distribution
14-578408 5.5 TI 6.5X140MM TRANSLATION TRANSLATION SCREW In distribution
2000-7625 8.5X25MM MULTIAXIAL RED.SCREW In distribution
14-503765 9.5 X 65MM MULTIAXIAL ILIAC SCREW, SST In distribution
2000-2755 9.5X55MM MULTIAXIAL SCREW In distribution
2000-1035 ARCHED CROSS CONNECTOR SMALL In distribution
14-503180 4.0 X 80MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-512640 8.5MM X 40MM UNIPLANAR SCREW In distribution
2000-7350C SCREW, 5.5MM X 50MM MULTIAXIAL In distribution
2000-5155E 55MM TI ALLOY CURVED ROD In distribution
14-505516 RIGHT ANGLE HOOK-5.5 SST In distribution
14-500265 DIA 5.5MM X 35MM MULTIAXIAL ILIAC SCREW 5.5 In distribution
14-500271 DIA 5.5MM X 65MM MULTIAXIAL In distribution
5006752E CROSS CONNECTOR, SMALL In distribution
2000-2180 4.0MM DIA X 80MM STANDARD MULTIAXIAL SCREW In distribution
14-578608 5.5 TI 8.5X140MM TRANSLATION TRANSLATION SCREW In distribution
14-512330R 5.5MM X 30MM REDUCTION UNIPLANAR SCREW In distribution
14-504655 8.5MM X 55MM FIXED SCREW 5.5 SST In distribution
2000-7635 8.5X35MM MULTIAXIAL RED.SCREW In distribution
2000-4765 9.5 X 65MM FIXED SCREW In distribution
2000-5558E EXTENDED LAMINAR HOOK, LARGE In distribution
2000-4885 10.5 X 85MM FIXED SCREW In distribution
2000-5465 65MM TI ALLOY CURVED ROD W/HEX In distribution
2000-2860 10.5X60MM MULTIAXIAL SCREW In distribution
14-500836E 3.5 mm x 3.5 mm Parallel Ti Wedding Band In distribution
2000-4325E 5.5 X 25MM FIXED SCREW In distribution
2000-5538 RIGHT OFFSET HOOK, SMALL (6MM) In distribution
14-578608R 5.5 TI 8.5X140MM TRANS REDUC TRANSLATION REDUCTION SCREW In distribution
2000-5130 30MM TI ALLOY CURVED ROD In distribution
2000-2570 7.5X70MM MULTIAXIAL SCREW In distribution
2000-5130 30MM TI ALLOY CURVED ROD In distribution
14-504685 8.5MM X 85MM FIXED SCREW 5.5 In distribution
14-504755 9.5MM X 55MM FIXED SCREW 5.5 In distribution
2000-2475 6.5X75MM MULTIAXIAL SCREW In distribution
14-503560 7.5 X 60MM MULTIAXIAL ILIAC In distribution
14-503375 5.5 X 75MM MULTIAXIAL ILIAC SCREW, SST In distribution
14-512850 10.5MM X 50MM UNIPLANAR SCREW In distribution
2000-7531 7.5MM X 30MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD In distribution
2000-7495 6.5X95MM MULTIAXIAL RED.SCREW In distribution
14-500362 DIA 10.5MM X 20MM MULTIAXIAL ILIAC SCREW 5.5 In distribution
14-502130 4.0 X 30MM MULTIAXIAL SCREW 5.5 SST In distribution
14-512790 9.5MM X 90MM UNIPLANAR SCREW In distribution
2000-2430E 6.5 x 30 mm Multiaxial Screw In distribution
5006763 22MM FIXED CROSS CONNECTOR In distribution
14-504185 4.0MM X 85MM FIXED SCREW 5.5 In distribution
14-503755 9.5 X 55MM MULTIAXIAL ILIAC In distribution
5006764E 24MM FIXED CROSS CONNECTOR In distribution
2000-5115 130MM TI ALLOY CURVED ROD In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

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Product Sold by Catalogue numbers
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Zenius Spinal System Medyssey Co., Ltd. 712

Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal 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