510(k) K972501 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
APOLLO REVISION/CONSTRAINED KNEE SYSTEM
| Applicant | Sulzer Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Oct 1, 1997 |
| Received | Jul 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972501
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2014 | Zimmer, Inc. Apollo" Revision/Constrained Knee System:
SZ0-16MM AK CCK TIB INSER
SZ1-11MM AK CCK TIB INSER
SZ1-16MM AK CCK TIB INSER
SZ1-22MM AK CCK TIB INSER
SZ1-30MM AK CCK TIB INSER
SZ2-11MM AK CCK TIB INSER
SZ Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.