510(k) K063303 ยท HRS Plate, Fixation, Bone
UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Nov 22, 2006 |
| Received | Nov 1, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063303
| 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 Plates and Screws (ZPS)
2.7 mm Cortical Screw SelfTapping, 14 mm Length 47482701401 Terminated |
HWC | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 5 consists of all products under product code HWC, and same usage:
Item no:
47482701001 2.7MM CORT. SCREW 10MM, S
47482701201 2.7MM CORT. SCREW 12MM, S
47482701401 2.7MM CORT. SCREW 14MM, Terminated |
HWC | None listed |
| Feb 20, 2014 | Zimmer, Inc. 1.5 X 6 CORT SCREW HEX/SE
2.0 X 6 CORT SCREW HEX/SE
2.0 X 10 CORT SCREW CRUCI
2.0 X 12 CORT SCREW CRUCI
2.0 X 14 CORT SCREW CRUCI
2.0 X 16 CORT SCREW HEX/S
2.0 X 16 CORT SCREW CRUCI
2.0 X 18 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.