510(k) K955271 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
MICRO-SEAL ACETABULAR SYSTEM
| Applicant | Whiteside Instruments, Creve Coeur MO, US |
| Decision | Substantially Equivalent, Jan 30, 1996 |
| Received | Nov 15, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955271
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2014 | Signal Medical Corporation Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648). Sizes 36x52x20; and 36x50x20.
Device is intended for use with Whiteside Biomechanics, Inc./ Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.