Polaris 5.5 TI Spinal System
72 catalogue numbers from 14-510645R, listed by Biomet Spine, United States, under Orthosis, Spinal Pedicle Fixation. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
72catalogue 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, Spinal Pedicle Fixation
Record
| 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 | 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 |
|---|---|---|
| 14-510645R | 5.5 TI 6.5X45MM TAPERED REDUC | In distribution |
| 14-578809R | 5.5 TI 10.5X145MM TRANS REDUC | In distribution |
| 14-578740 | 5.5 TI 9.5 X 40MM TRANSLATION | In distribution |
| 14-578735R | 5.5 TI 9.5X35MM TRANS REDUC | In distribution |
| 14-578440 | 5.5 TI 6.5X40MM TRANSLATION | In distribution |
| 14-578702R | 5.5 TI 9.5X110MM TRANS REDUC | In distribution |
| 14-578575R | 5.5 TI 7.5X75MM TRANS REDUC | In distribution |
| 14-578895R | 5.5 TI 10.5X95MM TRANS REDUC | In distribution |
| 14-578380 | 5.5 TI 5.5X80MM TRANSLATION | In distribution |
| 14-578806R | 5.5 TI 10.5X130MM TRANS REDUC | In distribution |
| 14-578520 | 5.5 TI 7.5X20MM TRANSLATION | In distribution |
| 14-510755R | 5.5 TI 7.5X55MM TAPERED REDUC | In distribution |
| 14-578206R | 5.5 TI 4.75X130MM TRANS REDUC | In distribution |
| 14-578685R | 5.5 TI 8.5X85MM TRANS REDUC | In distribution |
| 14-578445 | 5.5 TI 6.5X45MM TRANSLATION | In distribution |
| 14-578299 | 5.5 TI 4.75X100MM TRANSLATION | In distribution |
| 14-578825 | 5.5 TI 10.5 X 25MM TRANSLATION | In distribution |
| 14-510540 | 5.5 TI 5.5 X 40MM TAPERED MAS | In distribution |
| 14-578250R | 5.5 TI 4.75X50MM TRANS REDUC | In distribution |
| 14-578603 | 5.5 TI 8.5X115MM TRANSLATION | In distribution |
| 14-578608R | 5.5 TI 8.5X140MM TRANS REDUC | In distribution |
| 14-578606R | 5.5 TI 8.5X130MM TRANS REDUC | In distribution |
| 14-578810R | 5.5 TI 10.5X150MM TRANS REDUC | In distribution |
| 14-510650R | 5.5 TI 6.5X50MM TAPERED REDUC | In distribution |
| 14-578404 | 5.5 TI 6.5X120MM TRANSLATION | In distribution |
| 14-578704R | 5.5 TI 9.5X120MM TRANS REDUC | In distribution |
| 14-578899R | 5.5 TI 10.5X100MM TRANS REDUC | In distribution |
| 14-578675R | 5.5 TI 8.5X75MM TRANS REDUC | In distribution |
| 14-578670R | 5.5 TI 8.5X70MM TRANS REDUC | In distribution |
| 14-578210R | 5.5 TI 4.75X150MM TRANS REDUC | In distribution |
| 14-578280 | 5.5 TI 4.75X80MM TRANSLATION | In distribution |
| 14-578635 | 5.5 TI 8.5X35MM TRANSLATION | In distribution |
| 14-578450 | 5.5 TI 6.5X50MM TRANSLATION | In distribution |
| 14-578804R | 5.5 TI 10.5X120MM TRANS REDUC | In distribution |
| 14-578785R | 5.5 TI 9.5X85MM TRANS REDUC | In distribution |
| 14-578275R | 5.5 TI 4.75X75MM TRANS REDUC | In distribution |
| 14-578860 | 5.5 TI 10.5 X 60MM TRANSLATION | In distribution |
| 14-578870R | 5.5 TI 10.5X70MM TRANS REDUC | In distribution |
| 14-578820 | 5.5 TI 10.5 X 20MM TRANSLATION | In distribution |
| 14-578201R | 5.5 TI 4.75X105MM TRANS REDUC | In distribution |
| 14-578506R | 5.5 TI 7.5X130MM TRANS REDUC | In distribution |
| 14-510535 | 5.5 TI 5.5X35MM TAPERED MAS | In distribution |
| 14-578375R | 5.5 TI 5.5X75MM TRANS REDUC | In distribution |
| 14-578304 | 5.5 TI 5.5X120MM TRANSLATION | In distribution |
| 14-578207R | 5.5 TI 4.75X135MM TRANS REDUC | In distribution |
| 14-578808R | 5.5 TI 10.5X140MM TRANS REDUC | In distribution |
| 14-510560R | 5.5 TI 5.5X60MM TAPERED REDUC | In distribution |
| 14-578209R | 5.5 TI 4.75X145MM TRANS REDUC | In distribution |
| 14-578285R | 5.5 TI 4.75X85MM TRANS REDUC | In distribution |
| 14-578690R | 5.5 TI 8.5X90MM TRANS REDUC | In distribution |
| 14-578420R | 5.5 TI 6.5X20MM TRANS REDUC | In distribution |
| 14-578509 | 5.5 TI 7.5X145MM TRANSLATION | In distribution |
| 14-578340R | 5.5 TI 5.5X40MM TRANS REDUC | In distribution |
| 14-578204R | 5.5 TI 4.75X120MM TRANS REDUC | In distribution |
| 14-578695 | 5.5 TI 8.5X95MM TRANSLATION | In distribution |
| 14-578635R | 5.5 TI 8.5X35MM TRANS REDUC | In distribution |
| 14-578580R | 5.5 TI 7.5X80MM TRANS REDUC | In distribution |
| 14-578435R | 5.5 TI 6.5X35MM TRANS REDUC | In distribution |
| 14-578607 | 5.5 TI 8.5X135MM TRANSLATION | In distribution |
| 14-578340 | 5.5 TI 5.5X40MM TRANSLATION | In distribution |
| 14-578707 | 5.5 TI 9.5 X 135MM TRANSLATION | In distribution |
| 14-578695R | 5.5 TI 8.5X95MM TRANS REDUC | In distribution |
| 14-578806 | 5.5 TI 10.5 X130MM TRANSLATION | In distribution |
| 14-578725 | 5.5 TI 9.5 X 25MM TRANSLATION | In distribution |
| 14-578404R | 5.5 TI 6.5X120MM TRANS REDUC | In distribution |
| 14-510735R | 5.5 TI 7.5X35MM TAPERED REDUC | In distribution |
| 14-578495 | 5.5 TI 6.5X95MM TRANSLATION | In distribution |
| 14-578585 | 5.5 TI 7.5X85MM TRANSLATION | In distribution |
| 14-578802R | 5.5 TI 10.5X110MM TRANS REDUC | In distribution |
| 14-578245R | 5.5 TI 4.75X45MM TRANS REDUC | In distribution |
| 14-510540R | 5.5 TI 5.5X40MM TAPERED REDUC | In distribution |
| 14-510535R | 5.5 TI 5.5X35MM TAPERED REDUC | In distribution |
Same 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.