Data / Medical devices / France / Companion Spine
Companion Spine: FDA-registered device maker in Merignac Gironde, France, 2 510(k) clearances and 3 PMA approvals
Companion Spine is registered with the FDA (registration 3025435185) in Merignac Gironde, France. It lists 4 device types. The FDA files 2 510(k) clearances and 3 PMA approvals under its listings, the newest dated December 16, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025435185
- Address
- Immeuble le Bridge - 5 Allee des Acacias, Merignac Gironde, France, 33700
- Owner or operator
- Companion Spine (10086759)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 8, 2022
- Registered through
- 2026
- Brand names listed
- Bryan Cervical Disc Prosthesis, Cofix System, Coflex Interlaminar Technology, Companion Spine DIAM Instrumentation, DIAM Spinal Stabilization System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices | QLR | 2 | Specification developer | accessdata.fda.gov |
| Prosthesis, Intervertebral Disc | MJO | 3 | Specification developer | accessdata.fda.gov |
| Prosthesis, Spinous Process Spacer/Plate | NQO | 3 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Spinous Process Plate | PEK | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 16, 2025 | K253118 | Companion Spine DIAM Instrumentation | QLR | Substantially Equivalent | Companion Spine France | accessdata.fda.gov |
| August 4, 2020 | K201704 | CoFix System | PEK | Substantially Equivalent | Paradigm Spine GmbH | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 10, 2025 | P240043 | DIAM Spinal Stabilization System | NQO | 1 | April 1, 2026 | accessdata.fda.gov |
| October 17, 2012 | P110008 | COFLEX® INTERLAMINAR TECHNOLOGY | NQO | 14 | May 22, 2026 | accessdata.fda.gov |
| May 12, 2009 | P060023 | BRYAN CERVICAL DISC PROSTHESIS | MJO | 7 | March 18, 2020 | accessdata.fda.gov |
Compare with other makers
- All makers of Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices
- All makers of Prosthesis, Intervertebral Disc
- All makers of Spinous Process Plate
- All makers of Prosthesis, Spinous Process Spacer/Plate
Updated April 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.