Companion Spine France Sas: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Companion Spine France Sas”, plus 2 PMA decisions, across 2 product codes in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MJO | Prosthesis, Intervertebral Disc | 1 | 0 |
| NQO | Prosthesis, Spinous Process Spacer/Plate | 1 | 0 |
Review panels
- Orthopedic (2)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P240043 | PMA | DIAM Spinal Stabilization System | 2025-12-10 |
| P060023 | PMA | BRYAN CERVICAL DISC PROSTHESIS | 2009-05-12 |
Recalls
openFDA lists no recalls under a recalling firm named Companion Spine France Sas.
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 (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Companion Spine France Sas?
FDA lists 0 510(k) clearances under the applicant name “Companion Spine France Sas”, plus 2 PMA decisions, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Companion Spine France Sas?
The most frequent FDA product codes under this applicant name are MJO (Prosthesis, Intervertebral Disc, 1); NQO (Prosthesis, Spinous Process Spacer/Plate, 1).
Next steps
- See all 0 Companion Spine France Sas clearances with predicates and recalls
- Run predicate analysis for product code MJO, Companion Spine France Sas'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.