510(k) K140453 ยท KYJ Prosthesis, Finger, Constrained, Polymer
OSTEOTEC SILICONE FINGER IMPLANT
| Applicant | Osteotec, Ltd., Christchurch, Dorset, GB |
| Decision | Substantially Equivalent, Apr 17, 2015 |
| Received | Feb 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140453
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2025 | Osteotec Limited Brand Name: Osteotec
Product Name: Osteotec Silicone Finger Implant
Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5)
Software Version: N/A
Product Description: The Osteotec Silicon Open, Classified |
KYJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.