Spineart USA, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Spineart USA, Inc.”, plus 1 PMA decision, across 1 product code 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 |
Review panels
- Orthopedic (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250042 | PMA | BAGUERA®C Cervical Disc Prosthesis | 2026-08-10 |
Recalls
openFDA lists no recalls under a recalling firm named Spineart USA, Inc..
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.
Device clinical trials
An industry sponsor named Spineart USA, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT04564885: A Clinical Trial Comparing the BAGUERA C to the Marketed Mobi-C® for the Treatment of Cervical Disc Disease at 2 Contiguous Levels (Active not recruiting, started 2021-03-02)
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.
- Spineart (44 510(k)s)
- Spineart SA (14 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Spineart USA, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Spineart USA, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Spineart USA, Inc.?
The most frequent FDA product codes under this applicant name are MJO (Prosthesis, Intervertebral Disc, 1).
Next steps
- See all 0 Spineart USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MJO, Spineart USA, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.