510(k) K083772 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
COLUMBUS REVISION KNEE SYSTEM
| Applicant | Aesculap Implant System, Inc., Center Valley PA, US |
| Decision | Substantially Equivalent, Jun 4, 2009 |
| Received | Dec 18, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083772
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 21, 2020 | Aesculap Implant Systems LLC COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos.
NR068K
NR068Z
NR070K
NR070Z
NR071K
NR071Z
NR072K
NR072Z
NR073K
NR073Z
NR074K
NR074Z
NR075K
NR075Z
NR076K
NR076Z Terminated |
JWH | None listed |
| Nov 30, 2015 | Aesculap, Inc. Columbus Revision Knee System, EnduRo Knee System
Product Usage:
The Columbus Revision Knee System and EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint. Terminated |
JWH | None listed |
| Dec 13, 2013 | Aesculap, Inc. Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7 Terminated |
JWH | None listed |
| Feb 21, 2012 | Aesculap Implant Systems Columbus Tibia Plateau (component of the Columbus REVISION Knee System)
Product Usage - The Columbus Revision Knee System is indicated for use in reconstruction of the diseased knee joint caused by o Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.