510(k) K030367 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
COLUMBUS (PS)
| Applicant | Aesculap, Inc., Center Valley PA, US |
| Decision | Substantially Equivalent, Aug 21, 2003 |
| Received | Feb 4, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030367
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 21, 2020 | Aesculap Implant Systems LLC COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, model nos.
NN081K
NN082K
NN083K
NN084K
NN085K
NN086K
NN087K
NN088K
NN089K
Product Usage: Tibia-Plateaus are part of implants Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.