510(k) K053390 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
COLUMBUS (CR) TOTAL KNEE SYSTEM
| Applicant | Aesculap, Inc., Center Valley PA, US |
| Decision | Substantially Equivalent, Feb 6, 2006 |
| Received | Dec 5, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053390
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 21, 2020 | Aesculap Implant Systems LLC COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos.
NN469K
NN470K
NN471K
NN472K
NN473K
NN474K
NN475K
NN476K
NN477K
NN478K
NN479K
Product Usage: Tibia-Plateaus are pa Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.