510(k) K973412 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
NATURAL-KNEE II CONSTRAINED KNEE SYSTEM
| Applicant | Sulzer Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent for Some Indications, Dec 8, 1997 |
| Received | Sep 9, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973412
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2015 | Zimmer, Inc. Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component. Terminated |
JWH | None listed |
| Mar 20, 2014 | Zimmer, Inc. Natural-Knee II Constrained Knee System
NKII CCK TIB INS SZ00/0-L
NKII CCK TIB INS SZ1/2-LF
NKII CCK TIB INS SZ3-5 -L
NKII CCK TIB INS SZ00/0-R
NKII CCK TIB INS SZ3-5 -R
NKII CCK TIB INS SZ1/2-LF
NKII Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.