510(k) K091423 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
PROFEMUR HIP SYSTEM MODULAR NECKS
| Applicant | Wrightmedicaltechnologyinc, Arlington TN, US |
| Decision | Substantially Equivalent, Aug 25, 2009 |
| Received | May 13, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091423
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 9, 2020 | MicroPort Orthopedics Inc. PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions:
Item Number Description Description 2
PHAC1202 PROFEMUR NECK NEUTRAL SHORT COBALT CHROME
PHAC1204 PROFEMUR NECK NEUTRA Open, Classified |
LWJ | None listed |
| Sep 28, 2015 | MicroPort Orthopedics, Inc. PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper.
Orthopedic hip prosthesis component. Terminated |
MBL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.