510(k) K000306 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
PINNACLE ACETABULAR SYSTEM
| Applicant | DePuy Orthopaedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 23, 2000 |
| Received | Feb 1, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K000306
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2012 | DePuy Orthopaedics, Inc. Pinnacle Cancellous Screw
Packaging: Product is housed within a polyurethane protector; this is placed inside an uncoated Tyvek/PET peel pouch and sealed. This package is placed into a paperboard car Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.