Companion Spine France: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Companion Spine France” (first 2025, latest 2025), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 83 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2025 | 1 | 83 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Companion Spine France took a median 83 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 83 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NQO | Prosthesis, Spinous Process Spacer/Plate | 1 | 0 |
| QLR | Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices | 1 | 1 |
Review panels
- Orthopedic (2)
Most recent Companion Spine France 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253118 | Companion Spine DIAM Instrumentation | QLR | 2025-12-16 | 83 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P110008 | PMA | COFLEX® INTERLAMINAR TECHNOLOGY | 2012-10-17 |
Recalls
openFDA lists no recalls under a recalling firm named Companion Spine France.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Companion Medical, Inc. (5 510(k)s)
- Companion Products Intl. (2 510(k)s)
- Companion Spine France Sas (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Companion Spine France?
FDA lists 1 510(k) clearance under the applicant name “Companion Spine France” (first 2025, latest 2025), plus 1 PMA decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Companion Spine France?
The median time from FDA receipt to decision across 510(k)s cleared under the name Companion Spine France is 83 days.
Which FDA product codes appear under Companion Spine France?
The most frequent FDA product codes under this applicant name are NQO (Prosthesis, Spinous Process Spacer/Plate, 1); QLR (Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices, 1).
Next steps
- See all 1 Companion Spine France clearances with predicates and recalls
- Run predicate analysis for product code NQO, Companion Spine France's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.