Adira
The FDA filing identifies ADIRA as the ADIRA Lateral Plate System. It consists of one-, two- and four-hole thoracolumbar plates in varying sizes, used with bone screws. The two-hole and…
The FDA filing identifies ADIRA as the ADIRA Lateral Plate System. It consists of one-, two- and four-hole thoracolumbar plates in varying sizes, used with bone screws.
The two-hole and four-hole plates, when used with screws only, are intended to treat thoracolumbar spinal instability from listed causes including fracture and tumor.
Listed Item
ADIRA Plate, 1-Hole, 9.5mm, Up, RLX
One-Hole Plate Use
The one-hole plate is intended to stabilize allograft or autograft at one thoracolumbar level, aiding spinal fusion and providing temporary stabilization to augment fusion development. It is not intended for load-bearing applications.
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 | Globus Medical, Inc., United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K233735 |
| Record published | 2024-04-01 |
| Record revised | 2025-11-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1264.2023 | In distribution | |
| 1264.1007 | In distribution | |
| 1264.2123 | In distribution | |
| 1264.1109 | In distribution | |
| 1264.2115 | In distribution | |
| 1264.1108 | In distribution | |
| 1264.1107 | In distribution | |
| 1264.1011 | 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 |
|---|---|
| K233735 | 2024-01-25 |
| K232318 | 2023-10-31 |
| K192314 | 2019-10-23 |
| K183056 | 2019-04-19 |
| K181846 | 2018-11-06 |
| K133567 | 2014-02-20 |
| K121049 | 2012-06-27 |
| K120092 | 2012-04-13 |
| K092146 | 2009-11-16 |
| K092108 | 2009-08-13 |
| K081391 | 2008-07-03 |
| K070775 | 2007-04-19 |
| K062836 | 2006-12-19 |
| K062407 | 2006-09-06 |
| K040721 | 2004-06-17 |
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.