510(k) K083654 ยท HRS Plate, Fixation, Bone
ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM)
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Feb 26, 2009 |
| Received | Dec 10, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083654
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2019 | Zimmer Biomet, Inc. Universal Locking Plates Sterile, Item Nos.
47492800207
47492800303
47492800402
47492800403
47492800407
47492800502
47492800503
47492800507
47492800603
47492800607
47492800613
47492800702
47492800703 Terminated |
HRS | None listed |
| Feb 20, 2014 | Zimmer, Inc. 2.7 X 6 CORT SCREW/SELFTA
2.7 X 7 CORT SCREW/SELFTA
2.7 X 8 CORT SCREW/SELFTA
2.7 X 9 CORT SCREW/SELFTA
2.7 X 10 CORT SCREW/SELFT
2.7 X 12 CORT SCREW/SELFT
2.7 X 14 CORT SCREW/SELFT
2.7 X 16 CORT SCRE Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.