510(k) K122053 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
SHAPEMATCH CUTTING GUIDE
| Applicant | Stryker Corp., Alameda CA, US |
| Decision | Substantially Equivalent, Oct 24, 2012 |
| Received | Jul 13, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122053
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2013 | Stryker Howmedica Osteonics Corp. ShapeMatch Cutting Guides
Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty co Terminated |
MBH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.