Polaris 5.5 TI Spinal System
77 catalogue numbers from 14-578709, listed by Biomet Spine, United States, under Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
77catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shandong (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| 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 |
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | OSH |
| Device type | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| 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 |
|---|---|---|
| 14-578709 | 5.5 TI 9.5 X 145MM TRANSLATION | In distribution |
| 14-578499R | 5.5 TI 6.5X100MM TRANS REDUC | In distribution |
| 14-578585R | 5.5 TI 7.5X85MM TRANS REDUC | In distribution |
| 14-578699R | 5.5 TI 8.5X100MM TRANS REDUC | In distribution |
| 14-578290 | 5.5 TI 4.75X90MM TRANSLATION | In distribution |
| 14-578550 | 5.5 TI 7.5X50MM TRANSLATION | In distribution |
| 14-578810 | 5.5 TI 10.5 X150MM TRANSLATION | In distribution |
| 14-578645R | 5.5 TI 8.5X45MM TRANS REDUC | In distribution |
| 14-578480R | 5.5 TI 6.5X80MM TRANS REDUC | In distribution |
| 14-578701R | 5.5 TI 9.5X105MM TRANS REDUC | In distribution |
| 14-578602R | 5.5 TI 8.5X110MM TRANS REDUC | In distribution |
| 14-578609 | 5.5 TI 8.5X145MM TRANSLATION | In distribution |
| 14-578480 | 5.5 TI 6.5X80MM TRANSLATION | In distribution |
| 14-578535R | 5.5 TI 7.5X35MM TRANS REDUC | In distribution |
| 14-578708R | 5.5 TI 9.5X140MM TRANS REDUC | In distribution |
| 14-578504R | 5.5 TI 7.5X120MM TRANS REDUC | In distribution |
| 14-578465 | 5.5 TI 6.5X65MM TRANSLATION | In distribution |
| 14-578610R | 5.5 TI 8.5X150MM TRANS REDUC | In distribution |
| 14-578507R | 5.5 TI 7.5X135MM TRANS REDUC | In distribution |
| 14-578845 | 5.5 TI 10.5 X 45MM TRANSLATION | In distribution |
| 14-578809 | 5.5 TI 10.5 X145MM TRANSLATION | In distribution |
| 14-578595 | 5.5 TI 7.5X95MM TRANSLATION | In distribution |
| 14-578490R | 5.5 TI 6.5X90MM TRANS REDUC | In distribution |
| 14-578785 | 5.5 TI 9.5 X 85MM TRANSLATION | In distribution |
| 14-578630R | 5.5 TI 8.5X30MM TRANS REDUC | In distribution |
| 14-578703 | 5.5 TI 9.5 X 115MM TRANSLATION | In distribution |
| 14-578865R | 5.5 TI 10.5X65MM TRANS REDUC | In distribution |
| 14-578560R | 5.5 TI 7.5X60MM TRANS REDUC | In distribution |
| 14-578365 | 5.5 TI 5.5X65MM TRANSLATION | In distribution |
| 14-578706 | 5.5 TI 9.5 X 130MM TRANSLATION | In distribution |
| 14-578230R | 5.5 TI 4.75X30MM TRANS REDUC | In distribution |
| 14-578325R | 5.5 TI 5.5X25MM TRANS REDUC | In distribution |
| 14-578295 | 5.5 TI 4.75X95MM TRANSLATION | In distribution |
| 14-578780R | 5.5 TI 9.5X80MM TRANS REDUC | In distribution |
| 14-578795 | 5.5 TI 9.5 X 95MM TRANSLATION | In distribution |
| 14-578560 | 5.5 TI 7.5X60MM TRANSLATION | In distribution |
| 14-578208R | 5.5 TI 4.75X140MM TRANS REDUC | In distribution |
| 14-578755 | 5.5 TI 9.5 X 55MM TRANSLATION | In distribution |
| 14-578401 | 5.5 TI 6.5X105MM TRANSLATION | In distribution |
| 14-578402R | 5.5 TI 6.5X110MM TRANS REDUC | In distribution |
| 14-578590R | 5.5 TI 7.5X90MM TRANS REDUC | In distribution |
| 14-578470 | 5.5 TI 6.5X70MM TRANSLATION | In distribution |
| 14-578506 | 5.5 TI 7.5X130MM TRANSLATION | In distribution |
| 14-578865 | 5.5 TI 10.5 X 65MM TRANSLATION | In distribution |
| 14-578502 | 5.5 TI 7.5X110MM TRANSLATION | In distribution |
| 14-578395R | 5.5 TI 5.5X95MM TRANS REDUC | In distribution |
| 14-578455R | 5.5 TI 6.5X55MM TRANS REDUC | In distribution |
| 14-578708 | 5.5 TI 9.5 X 140MM TRANSLATION | In distribution |
| 14-578270R | 5.5 TI 4.75X70MM TRANS REDUC | In distribution |
| 14-578801 | 5.5 TI 10.5 X105MM TRANSLATION | In distribution |
| 14-578280R | 5.5 TI 4.75X80MM TRANS REDUC | In distribution |
| 14-578540 | 5.5 TI 7.5X40MM TRANSLATION | In distribution |
| 14-578450R | 5.5 TI 6.5X50MM TRANS REDUC | In distribution |
| 14-578545 | 5.5 TI 7.5X45MM TRANSLATION | In distribution |
| 14-578307R | 5.5 TI 5.5X135MM TRANS REDUC | In distribution |
| 14-578330R | 5.5 TI 5.5X30MM TRANS REDUC | In distribution |
| 14-578665 | 5.5 TI 8.5X65MM TRANSLATION | In distribution |
| 14-578350R | 5.5 TI 5.5X50MM TRANS REDUC | In distribution |
| 14-578885R | 5.5 TI 10.5X85MM TRANS REDUC | In distribution |
| 14-578725R | 5.5 TI 9.5X25MM TRANS REDUC | In distribution |
| 14-578855R | 5.5 TI 10.5X55MM TRANS REDUC | In distribution |
| 14-578670 | 5.5 TI 8.5X70MM TRANSLATION | In distribution |
| 14-578775 | 5.5 TI 9.5 X 75MM TRANSLATION | In distribution |
| 14-578445R | 5.5 TI 6.5X45MM TRANS REDUC | In distribution |
| 14-578875 | 5.5 TI 10.5 X 75MM TRANSLATION | In distribution |
| 14-578850R | 5.5 TI 10.5X50MM TRANS REDUC | In distribution |
| 14-578760 | 5.5 TI 9.5 X 60MM TRANSLATION | In distribution |
| 14-578765R | 5.5 TI 9.5X65MM TRANS REDUC | In distribution |
| 14-578390R | 5.5 TI 5.5X90MM TRANS REDUC | In distribution |
| 14-578460 | 5.5 TI 6.5X60MM TRANSLATION | In distribution |
| 14-578209 | 5.5 TI 4.75X145MM TRANSLATION | In distribution |
| 14-578260R | 5.5 TI 4.75X60MM TRANS REDUC | In distribution |
| 14-578608 | 5.5 TI 8.5X140MM TRANSLATION | In distribution |
| 14-578410 | 5.5 TI 6.5X150MM TRANSLATION | In distribution |
| 14-578230 | 5.5 TI 4.75X30MM TRANSLATION | In distribution |
| 14-578304R | 5.5 TI 5.5X120MM TRANS REDUC | In distribution |
| 14-578505R | 5.5 TI 7.5X125MM TRANS REDUC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Creo | Globus Medical, Inc. | 1,821 |
| ReLine | Nuvasive, Inc. | 1,093 |
| Olympic | Astura Medical | 951 |
| Nex-D2 | Next Orthosurgical | 887 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 876 |
| Arsenal | Alphatec Spine, Inc. | 820 |
| Apex-DL Spine System | Spinecraft LLC | 691 |
| Polaris™ 4.75 Spinal System | Biomet Spine | 413 |
| Expedium | Medos International Sàrl | 400 |
| Implanet Spine System | Implanet | 386 |
| Everest® Spinal System | VB Spine LLC | 299 |
| Arsenal Deformity Spinal Fixation System | Alphatec Spine, Inc. | 258 |
Showing 12 of 73. All products under Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
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.