510(k) K093474 ยท HRS Plate, Fixation, Bone
DEPUY FRACTURE AND FUSION PLATING SYSTEM
| Applicant | DePuy Orthopaedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Feb 2, 2010 |
| Received | Nov 6, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093474
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 25, 2017 | Zimmer Biomet, Inc. A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403 Terminated |
HRS | None listed |
| Jul 8, 2015 | Biomet, Inc. A.L.P.S. Foot Locking Calcaneus Plate,Small-Right.
Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries. Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.