510(k) K060710 ยท HWC Screw, Fixation, Bone
UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Apr 26, 2006 |
| Received | Mar 16, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060710
| 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)
3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001
3.5 mm Cortical Screw SelfTapping, 14 mm Length 47483501401
3.5 mm Cortical Screw SelfTapping, 16 mm Lengt Terminated |
HWC | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 8 consists of all products under product code HWC, and same usage:
Item no:
47483501201 3.5MM CORT. SCREW 12MM LN
47483501401 3.5MM CORT. SCREW 14MM LN
47483501601 3.5MM CORT. SCREW 16MM LN
4 Terminated |
HWC | None listed |
| Dec 9, 2015 | Zimmer Biomet, Inc. Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate
Straight 11 Holes 144mm Length
Zimmer Universal Locking System 3.5mm Locking Dual Compression Plate
8 Holes 105mm Length.
Indicated Terminated |
HRS | 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.