510(k) K082527 ยท HRS Plate, Fixation, Bone
ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Dec 18, 2008 |
| Received | Sep 2, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082527
| 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 |
| May 16, 2016 | Zimmer Manufacturing B.V. Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801 Terminated |
HWC | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 6 consists of all products under product code HWC, and same usage:
Item no:
47493501001 3.5 X 10 CORT SCREW SELFT
47493501801 3.5 X 18 CORT SCREW SELFT
Product Usage:
A smooth or threaded m Terminated |
HWC | 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 |
| Feb 20, 2014 | Zimmer, Inc. 3.5 X 10 CORT SCREW SELFT
3.5 X 12 CORT SCREW SELFT
3.5 X 14 CORT SCREW SELFT
3.5 X 16 CORT SCREW SELFT
3.5 X 18 CORT SCREW SELFT
3.5 X 20 CORT SCREW SELFT
3.5 X 22 CORT SCREW SELFT
3.5 X 24 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.