510(k) K111492 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS
| Applicant | Materialise NV, Leuven, BE |
| Decision | Substantially Equivalent, Oct 13, 2011 |
| Received | May 31, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111492
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 14, 2012 | Materialise USA LLC PATIENT SPECIFIC INSTRUMENTS
LPS-FLEX PIN GUIDES (FEMUR AND TIBIA)
NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE
Patient ID--0242-LF
Manufactured by Materialise, Plymouth, MI
Distributed by Zimmer, W Terminated |
JWH | None listed |
| May 14, 2012 | Materialise USA LLC PATIENT SPECIFIC INSTRUMENTS
N-K FLEX PIN GUIDES (FEMUR AND TIBIA)
NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE
Patient ID ..- 0864-R3 Manufactured by Materialise, Plymouth, MI
Distributed by Zimmer Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.