510(k) K110415 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
SIGNATURE PLANNER / SIGNATURE GUIDES
| Applicant | Materialise NV, Leuven, BE |
| Decision | Substantially Equivalent, May 16, 2011 |
| Received | Feb 14, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110415
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 3, 2014 | Materialise USA LLC REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE
SIGNATURE
M PKA GDE/MDL SET SML-MP
DD.....R-FEB55RKA-T JA-A01 05551
PKA POST CUT SML-PKA MICROPLASTY
CUSTOM-MADE DEVICE
non-sterile
The Terminated |
HRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.