510(k) K061211 ยท HRS Plate, Fixation, Bone
NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES
| Applicant | Zimmer GmbH, Warsaw IN, US |
| Decision | Substantially Equivalent, Jun 14, 2006 |
| Received | May 1, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061211
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2019 | Zimmer Biomet, Inc. NCB Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item Nos. 0202261205
0202261207
0202261209
0202261213
0202261305
0202261307
0202261309
0202261313 Terminated |
HRS | None listed |
| Nov 6, 2012 | Zimmer, Inc. NCB cancellous screw Terminated |
HWC | None listed |
| Nov 6, 2012 | Zimmer, Inc. NCB screw 4.0 self-tapping Terminated |
HWC | None listed |
| Nov 6, 2012 | Zimmer, Inc. NCB-PT lateral proximal 3 hole tibial plate Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.