510(k) K964381 ยท KYI Prosthesis, Wrist, Carpal Trapezium
AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT
| Applicant | Avanta Orthopaedics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jan 22, 1997 |
| Received | Nov 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964381
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 9, 2003 | Avanta Orthopaedics, Inc. Finger Joint Implants, Silicone
Models TRL-10 and TRL-20 Terminated |
KYI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.