Polaris 5.5 TI Spinal System
69 catalogue numbers from 14-510550, listed by Biomet Spine, United States, under Orthosis, Spondylolisthesis Spinal Fixation. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
69catalogue 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.
| 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
| 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 6) |
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 number | Size | Status |
|---|---|---|
| 14-510550 | 5.5 TI 5.5 X 50MM TAPERED MAS | In distribution |
| 14-578540R | 5.5 TI 7.5X40MM TRANS REDUC | In distribution |
| 14-578245 | 5.5 TI 4.75X45MM TRANSLATION | In distribution |
| 14-578306R | 5.5 TI 5.5X130MM TRANS REDUC | In distribution |
| 14-578485 | 5.5 TI 6.5X85MM TRANSLATION | In distribution |
| 14-578555 | 5.5 TI 7.5X55MM TRANSLATION | In distribution |
| 14-578875R | 5.5 TI 10.5X75MM TRANS REDUC | In distribution |
| 14-578535 | 5.5 TI 7.5X35MM TRANSLATION | In distribution |
| 14-578406 | 5.5 TI 6.5X130MM TRANSLATION | In distribution |
| 14-578395 | 5.5 TI 5.5X95MM TRANSLATION | In distribution |
| 14-578680 | 5.5 TI 8.5X80MM TRANSLATION | In distribution |
| 14-510650 | 5.5 TI 6.5 X 50MM TAPERED MAS | In distribution |
| 14-578805R | 5.5 TI 10.5X125MM TRANS REDUC | In distribution |
| 14-578807R | 5.5 TI 10.5X135MM TRANS REDUC | In distribution |
| 14-578880 | 5.5 TI 10.5 X 80MM TRANSLATION | In distribution |
| 14-510555R | 5.5 TI 5.5X55MM TAPERED REDUC | In distribution |
| 14-578208 | 5.5 TI 4.75X140MM TRANSLATION | In distribution |
| 14-578220 | 5.5 TI 4.75X20MM TRANSLATION | In distribution |
| 14-578675 | 5.5 TI 8.5X75MM TRANSLATION | In distribution |
| 14-578610 | 5.5 TI 8.5X150MM TRANSLATION | In distribution |
| 14-578207 | 5.5 TI 4.75X135MM TRANSLATION | In distribution |
| 14-510545 | 5.5 TI 5.5 X 45MM TAPERED MAS | In distribution |
| 14-510545R | 5.5 TI 5.5X40MM TAPERED REDUC | In distribution |
| 14-578870 | 5.5 TI 10.5 X 70MM TRANSLATION | In distribution |
| 14-578285 | 5.5 TI 4.75X85MM TRANSLATION | In distribution |
| 14-578701 | 5.5 TI 9.5 X 105MM TRANSLATION | In distribution |
| 14-578765 | 5.5 TI 9.5 X 65MM TRANSLATION | In distribution |
| 14-578745R | 5.5 TI 9.5X45MM TRANS REDUC | In distribution |
| 14-578403 | 5.5 TI 6.5X115MM TRANSLATION | In distribution |
| 14-578804 | 5.5 TI 10.5 X120MM TRANSLATION | In distribution |
| 14-578690 | 5.5 TI 8.5X90MM TRANSLATION | In distribution |
| 14-578399 | 5.5 TI 5.5X100MM TRANSLATION | In distribution |
| 14-578401R | 5.5 TI 6.5X105MM TRANS REDUC | In distribution |
| 14-578399R | 5.5 TI 5.5X100MM TRANS REDUC | In distribution |
| 14-578504 | 5.5 TI 7.5X120MM TRANSLATION | In distribution |
| 14-510635 | 5.5 TI 6.5 X 35MM TAPERED MAS | In distribution |
| 14-578630 | 5.5 TI 8.5X30MM TRANSLATION | In distribution |
| 14-578820R | 5.5 TI 10.5X20MM TRANS REDUC | In distribution |
| 14-578205R | 5.5 TI 4.75X125MM TRANS REDUC | In distribution |
| 14-578830R | 5.5 TI 10.5X30MM TRANS REDUC | In distribution |
| 14-510760 | 5.5 TI 7.5 X 60MM TAPERED MAS | In distribution |
| 14-578201 | 5.5 TI 4.75X105MM TRANSLATION | In distribution |
| 14-578699 | 5.5 TI 8.5X100MM TRANSLATION | In distribution |
| 14-578603R | 5.5 TI 8.5X115MM TRANS REDUC | In distribution |
| 14-578570 | 5.5 TI 7.5X70MM TRANSLATION | In distribution |
| 14-578409R | 5.5 TI 6.5X145MM TRANS REDUC | In distribution |
| 14-578855 | 5.5 TI 10.5 X 55MM TRANSLATION | In distribution |
| 14-578890R | 5.5 TI 10.5X90MM TRANS REDUC | In distribution |
| 14-578308 | 5.5 TI 5.5X140MM TRANSLATION | In distribution |
| 14-578520R | 5.5 TI 7.5X20MM TRANS REDUC | In distribution |
| 14-578655R | 5.5 TI 8.5X55MM TRANS REDUC | In distribution |
| 14-578640 | 5.5 TI 8.5X40MM TRANSLATION | In distribution |
| 14-510740R | 5.5 TI 7.5X40MM TAPERED REDUC | In distribution |
| 14-578885 | 5.5 TI 10.5 X 85MM TRANSLATION | In distribution |
| 14-578704 | 5.5 TI 9.5 X 120MM TRANSLATION | In distribution |
| 14-578235 | 5.5 TI 4.75X35MM TRANSLATION | In distribution |
| 14-578370 | 5.5 TI 5.5X70MM TRANSLATION | In distribution |
| 14-510660R | 5.5 TI 6.5X60MM TAPERED REDUC | In distribution |
| 14-510660 | 5.5 TI 6.5 X 60MM TAPERED MAS | In distribution |
| 14-578760R | 5.5 TI 9.5X60MM TRANS REDUC | In distribution |
| 14-578625 | 5.5 TI 8.5X25MM TRANSLATION | In distribution |
| 14-510745 | 5.5 TI 7.5 X 45MM TAPERED MAS | In distribution |
| 14-578385R | 5.5 TI 5.5X85MM TRANS REDUC | In distribution |
| 14-578250 | 5.5 TI 4.75X50MM TRANSLATION | In distribution |
| 14-578306 | 5.5 TI 5.5X130MM TRANSLATION | In distribution |
| 14-578420 | 5.5 TI 6.5X20MM TRANSLATION | In distribution |
| 14-578835R | 5.5 TI 10.5X35MM TRANS REDUC | In distribution |
| 14-578290R | 5.5 TI 4.75X90MM TRANS REDUC | In distribution |
| 14-578510 | 5.5 TI 7.5X150MM TRANSLATION | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,144 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 2,177 |
| ReLine | Nuvasive, Inc. | 2,010 |
| Creo | Globus Medical, Inc. | 1,619 |
| Perfix™ Spinal System | CG MedTech Co., Ltd. | 1,476 |
| Apex Spine System | Spinecraft LLC | 1,193 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| 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.