510(k) K081759 ยท HRS Plate, Fixation, Bone
NCB POLYAXIAL LOCKING PLATE SYSTEM, PROXIMAL HUMERAL PLATES, ZIMMER UNIVERSAL LOCKING SYSTEM, 3.5MM TIVANIUM TI-6AL-4V
| Applicant | Zimmer GmbH, Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 16, 2008 |
| Received | Jun 20, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081759
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2019 | Zimmer Biomet, Inc. NCB-PH Plate with 4/5/7 Lock Holes, Item Nos. 0202262104
0202262105
0202262107 Terminated |
HWC | None listed |
| Nov 6, 2012 | Zimmer, Inc. NCB-PH Plate Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.