510(k) K931651 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
NATURAL-KNEE CONGRUENT TIBIAL INSERT WITH SCREW
| Applicant | Intermedics Orthopedics, Austin TX, US |
| Decision | Substantially Equivalent for Some Indications, Jul 18, 1994 |
| Received | Apr 5, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K931651
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2014 | Zimmer, Inc. Natural-Knee Congruent Tibial Insert with Screw:
SF-CON TIB INS LT SZ1/2 1
SF-CON TIB INS RT SZ1/2 9
SF-CON TIB INS RT SZ3/4/5 Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.