510(k) K012091 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
PRO-FEMUR
| Applicant | Wrightmedicaltechnologyinc, Arlington TN, US |
| Decision | Substantially Equivalent, Oct 3, 2001 |
| Received | Jul 5, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K012091
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 3, 2017 | MicroPort Orthopedics Inc. PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN
Instruments support the implantation of implants. Broach handles mate to the broach to allow for prep Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.