Corra
corra™, Cervical Anterior Segmental Plate, 2 Hole Right, C81 Plan
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 | Carlsmed, Inc., United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K252611 |
| Record published | 2026-01-30 |
| Record revised | 2026-03-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2026-03-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ASP.3U.C71.03 | In distribution | |
| ASP.3D.C67.02 | In distribution | |
| ASP.3D.C45.03 | In distribution | |
| AMP.2.C61.02 | In distribution | |
| 1426.14.3 | In distribution | |
| ASP.2R.C81.02 | In distribution | |
| ASP.4.C34.02 | In distribution | |
| 1426.16.2 | In distribution | |
| AMP.4.C48.03 | In distribution | |
| AMP.4.C26.03 | In distribution | |
| ASP.3U.C23.02 | In distribution | |
| AMP.5.C27.02 | In distribution | |
| ASP.2L.C67.02 | In distribution | |
| AMP.5.C41.02 | In distribution | |
| ASP.3D.C71.02 | In distribution | |
| AMP.3.C25.02 | In distribution | |
| AMP.1.C45.02 | In distribution | |
| 1426.12.2 | In distribution | |
| ASP.2R.C81.03 | In distribution | |
| ASP.3D.C34.03 | In distribution | |
| ASP.2L.C78.02 | In distribution | |
| ASP.3U.C81.03 | In distribution | |
| ASP.4.C56.03 | In distribution | |
| AMP.1.C71.02 | In distribution | |
| ASP.2L.C56.02 | In distribution | |
| ASP.2L.C23.02 | In distribution | |
| ASP.4.C23.02 | In distribution | |
| ASP.3D.C78.02 | In distribution | |
| AMP.2.C24.02 | In distribution | |
| AMP.2.C35.02 | In distribution | |
| AMP.2.C35.03 | In distribution | |
| AMP.4.C41.03 | In distribution | |
| ASP.2R.C56.03 | In distribution | |
| ASP.2R.C78.02 | In distribution | |
| 1426.18.2 | In distribution | |
| ASP.3U.C34.03 | In distribution | |
| ASP.2L.C34.02 | In distribution | |
| ASP.2R.C78.03 | In distribution | |
| ASP.3D.C56.03 | In distribution | |
| AMP.2.C61.03 | In distribution | |
| AMP.4.C37.03 | In distribution | |
| ASP.4.C56.02 | In distribution | |
| 1426.14.2 | In distribution | |
| AMP.5.C38.03 | In distribution | |
| ASP.2L.C45.02 | In distribution | |
| AMP.1.C56.02 | In distribution | |
| ASP.3U.C56.02 | In distribution | |
| ASP.2R.C23.02 | In distribution | |
| ASP.4.C81.03 | In distribution | |
| AMP.3.C51.03 | In distribution | |
| 1426.12.3 | In distribution | |
| AMP.4.C51.03 | In distribution | |
| AMP.3.C61.02 | In distribution | |
| AMP.1.C78.03 | In distribution | |
| AMP.1.C23.02 | In distribution | |
| 1426.16.3 | In distribution | |
| ASP.4.C71.03 | In distribution | |
| AMP.3.C58.02 | In distribution | |
| AMP.1.C67.03 | In distribution | |
| ASP.2L.C81.03 | In distribution | |
| 1421.12.3 | In distribution | |
| AMP.4.C37.02 | In distribution | |
| AMP.2.C57.02 | In distribution | |
| ASP.2R.C67.02 | In distribution | |
| ASP.3U.C71.02 | In distribution | |
| AMP.2.C68.03 | In distribution | |
| AMP.2.C68.02 | In distribution | |
| 1421.16.3 | In distribution | |
| AMP.4.C26.02 | In distribution | |
| ASP.2R.C71.03 | In distribution | |
| ASP.3D.C71.03 | In distribution | |
| AMP.5.C38.02 | In distribution | |
| ASP.3D.C34.02 | In distribution | |
| ASP.4.C67.03 | In distribution | |
| ASP.4.C23.03 | In distribution | |
| AMP.3.C47.02 | In distribution | |
| AMP.1.C45.03 | In distribution | |
| ASP.3D.C56.02 | In distribution | |
| 1616 | In distribution | |
| 1421.14.2 | In distribution | |
| ASP.3U.C67.02 | In distribution | |
| ASP.3U.C45.02 | In distribution | |
| AMP.2.C46.03 | In distribution | |
| 1610 | In distribution | |
| AMP.1.C78.02 | In distribution | |
| 1620 | In distribution | |
| ASP.3U.C23.03 | In distribution | |
| AMP.5.C41.03 | In distribution | |
| AMP.1.C23.03 | In distribution | |
| ASP.4.C45.03 | In distribution | |
| ASP.2L.C23.03 | In distribution | |
| ASP.3D.C81.02 | In distribution | |
| ASP.2R.C34.02 | In distribution | |
| ASP.2L.C71.02 | In distribution | |
| AMP.2.C57.03 | In distribution | |
| ASP.3D.C45.02 | In distribution | |
| 1426.18.3 | In distribution | |
| AMP.4.C41.02 | In distribution | |
| 1421.18.2 | In distribution | |
| AMP.1.C34.02 | In distribution | |
| AMP.2.C24.03 | In distribution | |
| ASP.2R.C71.02 | In distribution | |
| AMP.2.C46.02 | In distribution | |
| ASP.3U.C78.03 | In distribution | |
| AMP.3.C47.03 | In distribution | |
| ASP.3D.C81.03 | In distribution | |
| ASP.2L.C34.03 | In distribution | |
| 1421.12.2 | In distribution | |
| ASP.4.C78.02 | In distribution | |
| AMP.3.C36.03 | In distribution | |
| ASP.2L.C56.03 | In distribution | |
| AMP.3.C51.02 | In distribution | |
| AMP.5.C27.03 | In distribution | |
| ASP.3D.C78.03 | In distribution | |
| ASP.2R.C45.03 | In distribution | |
| ASP.4.C67.02 | In distribution | |
| AMP.3.C36.02 | In distribution | |
| AMP.1.C81.02 | In distribution | |
| ASP.3U.C67.03 | In distribution | |
| ASP.4.C45.02 | In distribution | |
| ASP.4.C34.03 | In distribution | |
| ASP.3U.C34.02 | In distribution | |
| ASP.3U.C78.02 | In distribution | |
| 1421.18.3 | In distribution | |
| ASP.4.C78.03 | In distribution | |
| ASP.2L.C71.03 | In distribution | |
| ASP.2L.C45.03 | In distribution | |
| ASP.3U.C45.03 | In distribution | |
| ASP.3U.C56.03 | In distribution | |
| ASP.2R.C34.03 | In distribution | |
| AMP.2.C71.03 | In distribution | |
| AMP.5.C31.03 | In distribution | |
| AMP.3.C58.03 | In distribution | |
| AMP.1.C34.03 | In distribution | |
| ASP.3D.C23.03 | In distribution | |
| AMP.1.C67.02 | In distribution | |
| AMP.1.C56.03 | In distribution | |
| AMP.1.C71.03 | In distribution | |
| AMP.1.C81.03 | In distribution | |
| ASP.3D.C23.02 | In distribution | |
| ASP.2R.C56.02 | In distribution | |
| AMP.3.C25.03 | In distribution | |
| ASP.2R.C23.03 | In distribution | |
| AMP.2.C71.02 | In distribution | |
| ASP.3D.C67.03 | In distribution | |
| AMP.3.C61.03 | In distribution | |
| ASP.2R.C45.02 | In distribution | |
| ASP.2R.C67.03 | In distribution | |
| 1421.16.2 | In distribution | |
| ASP.4.C81.02 | In distribution | |
| ASP.4.C71.02 | In distribution | |
| 1421.14.3 | In distribution | |
| AMP.5.C31.02 | In distribution | |
| ASP.2L.C78.03 | In distribution | |
| ASP.2L.C81.02 | In distribution | |
| ASP.3U.C81.02 | In distribution | |
| ASP.2L.C67.03 | In distribution | |
| AMP.4.C48.02 | In distribution | |
| AMP.4.C51.02 | In distribution | |
| 1426.18.3 | Withdrawn |
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 |
|---|---|
| K260570 | 2026-04-22 |
| K252611 | 2025-12-22 |
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.