510(k) K934381 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
APOLLO KNEE TIBIAL BASEPLATE/KNEE TIBIAL INSERT
| Applicant | Intermedics Orthopedics, Austin TX, US |
| Decision | Substantially Equivalent for Some Indications, Feb 8, 1995 |
| Received | Sep 8, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934381
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2014 | Zimmer, Inc. Apollo Knee Tibial Baseplate/Knee Tibial Insert:
CONG TIB INS SZ0/19MM APO
CONG TIB INS SZ0/22MM APO
CONG TIB INS SZ1/9MM APOL
CONG TIB INS SZ1/11MM APO
CONG TIB INS SZ1/19MM APO
CONG TIB INS SZ2/13MM Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.