510(k) K955778 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM
| Applicant | Intermedics Orthopedics, Austin TX, US |
| Decision | Substantially Equivalent for Some Indications, Mar 8, 1996 |
| Received | Dec 20, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955778
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2014 | Zimmer, Inc. Natural-Knee II - Unicompartmental Knee Prosthesis:
CONG TIB INS SZ1/2 9MM UN
CONG TIB INS SZ1/2 11MM U
CONG TIB INS SZ1/2 13MM U
CONG TIB INS SZ3/4 9MM UN
CONG TIB INS SZ3/4 11MM U
CONG TIB INS SZ3/4 Terminated |
HRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.