510(k) K071117 ยท KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS
| Applicant | DePuy Orthopaedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, May 18, 2007 |
| Received | Apr 20, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071117
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2012 | DePuy Orthopaedics, Inc. S-Rom Total Hip System Poly Liner
Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET pouch and sealed; the foil pouch and Tyvek/PET pouch Terminated |
KWZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.