510(k) K082300 ยท HRS Plate, Fixation, Bone
ANATOMIC LOCKING PLATING SYSTEM
| Applicant | DePuy Orthopaedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Feb 18, 2009 |
| Received | Aug 12, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082300
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2015 | Biomet, Inc. A.L.P.S. 4.0mm Cancellous Locking Screws
intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones. Terminated |
HRS | None listed |
| Jan 10, 2014 | Biomet, Inc. Locking Cortical Screw
3.5mmX38mm
REF 8161-35-038 Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.