Polaris 5.5 TI Spinal System
60 catalogue numbers from 14-578380R, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
60catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| 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 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| 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 |
|---|---|---|
| 14-578380R | 5.5 TI 5.5X80MM TRANS REDUC | In distribution |
| 14-578860R | 5.5 TI 10.5X60MM TRANS REDUC | In distribution |
| 14-578685 | 5.5 TI 8.5X85MM TRANSLATION | In distribution |
| 14-578660R | 5.5 TI 8.5X60MM TRANS REDUC | In distribution |
| 14-578803 | 5.5 TI 10.5 X115MM TRANSLATION | In distribution |
| 14-578680R | 5.5 TI 8.5X80MM TRANS REDUC | In distribution |
| 14-578825R | 5.5 TI 10.5X25MM TRANS REDUC | In distribution |
| 14-578202R | 5.5 TI 4.75X110MM TRANS REDUC | In distribution |
| 14-578430R | 5.5 TI 6.5X30MM TRANS REDUC | In distribution |
| 14-578605 | 5.5 TI 8.5X125MM TRANSLATION | In distribution |
| 14-578505 | 5.5 TI 7.5X125MM TRANSLATION | In distribution |
| 14-578835 | 5.5 TI 10.5 X 35MM TRANSLATION | In distribution |
| 14-578730R | 5.5 TI 9.5X30MM TRANS REDUC | In distribution |
| 14-578365R | 5.5 TI 5.5X65MM TRANS REDUC | In distribution |
| 14-578320 | 5.5 TI 5.5X20MM TRANSLATION | In distribution |
| 14-578605R | 5.5 TI 8.5X125MM TRANS REDUC | In distribution |
| 14-578845R | 5.5 TI 10.5X45MM TRANS REDUC | In distribution |
| 14-578385 | 5.5 TI 5.5X85MM TRANSLATION | In distribution |
| 14-578570R | 5.5 TI 7.5X70MM TRANS REDUC | In distribution |
| 14-578899 | 5.5 TI 10.5 X100MM TRANSLATION | In distribution |
| 14-578490 | 5.5 TI 6.5X90MM TRANSLATION | In distribution |
| 14-578305R | 5.5 TI 5.5X125MM TRANS REDUC | In distribution |
| 14-510745R | 5.5 TI 7.5X45MM TAPERED REDUC | In distribution |
| 14-578425R | 5.5 TI 6.5X25MM TRANS REDUC | In distribution |
| 14-578707R | 5.5 TI 9.5X135MM TRANS REDUC | In distribution |
| 14-578503R | 5.5 TI 7.5X115MM TRANS REDUC | In distribution |
| 14-578265R | 5.5 TI 4.75X65MM TRANS REDUC | In distribution |
| 14-578270 | 5.5 TI 4.75X70MM TRANSLATION | In distribution |
| 14-578403R | 5.5 TI 6.5X115MM TRANS REDUC | In distribution |
| 14-578620R | 5.5 TI 8.5X20MM TRANS REDUC | In distribution |
| 14-578255R | 5.5 TI 4.75X55MM TRANS REDUC | In distribution |
| 14-578407R | 5.5 TI 6.5X135MM TRANS REDUC | In distribution |
| 14-578499 | 5.5 TI 6.5X100MM TRANSLATION | In distribution |
| 14-578775R | 5.5 TI 9.5X75MM TRANS REDUC | In distribution |
| 14-510640R | 5.5 TI 6.5X40MM TAPERED REDUC | In distribution |
| 14-578310 | 5.5 TI 5.5X150MM TRANSLATION | In distribution |
| 14-578405 | 5.5 TI 6.5X125MM TRANSLATION | In distribution |
| 14-578602 | 5.5 TI 8.5X110MM TRANSLATION | In distribution |
| 14-578225 | 5.5 TI 4.75X25MM TRANSLATION | In distribution |
| 14-578350 | 5.5 TI 5.5X50MM TRANSLATION | In distribution |
| 14-578604R | 5.5 TI 8.5X120MM TRANS REDUC | In distribution |
| 14-578555R | 5.5 TI 7.5X55MM TRANS REDUC | In distribution |
| 14-578335R | 5.5 TI 5.5X35MM TRANS REDUC | In distribution |
| 14-578265 | 5.5 TI 4.75X65MM TRANSLATION | In distribution |
| 14-578205 | 5.5 TI 4.75X125MM TRANSLATION | In distribution |
| 14-578510R | 5.5 TI 7.5X150MM TRANS REDUC | In distribution |
| 14-578509R | 5.5 TI 7.5X145MM TRANS REDUC | In distribution |
| 14-578360 | 5.5 TI 5.5X60MM TRANSLATION | In distribution |
| 14-578325 | 5.5 TI 5.5X25MM TRANSLATION | In distribution |
| 14-578730 | 5.5 TI 9.5 X 30MM TRANSLATION | In distribution |
| 14-510655 | 5.5 TI 6.5 X 55MM TAPERED MAS | In distribution |
| 14-578606 | 5.5 TI 8.5X130MM TRANSLATION | In distribution |
| 14-510555 | 5.5 TI 5.5 X 55MM TAPERED MAS | In distribution |
| 14-578360R | 5.5 TI 5.5X60MM TRANS REDUC | In distribution |
| 14-578530 | 5.5 TI 7.5X30MM TRANSLATION | In distribution |
| 14-578709R | 5.5 TI 9.5X145MM TRANS REDUC | In distribution |
| 14-578299R | 5.5 TI 4.75X100MM TRANS REDUC | In distribution |
| 14-578302 | 5.5 TI 5.5X110MM TRANSLATION | In distribution |
| 14-578203 | 5.5 TI 4.75X115MM TRANSLATION | In distribution |
| 14-578240R | 5.5 TI 4.75X40MM TRANS REDUC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K103393 | 2011-02-02 |
| K080646 | 2008-05-02 |
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.