510(k) K143188 ยท HWC Screw, Fixation, Bone
3.Omm Biomet Cannulated Screw System
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, Dec 30, 2014 |
| Received | Nov 5, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143188
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2020 | Biomet, Inc. 3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009787
110009790, 110009794, 110009796, 110009798, 110009800 - Product Usage: Fracture fixationof Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.