510(k) K142658 ยท HWC Screw, Fixation, Bone
Biomet Headless Compression and Twist-off Screws
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, Nov 13, 2014 |
| Received | Sep 18, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142658
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 28, 2019 | Zimmer Biomet, Inc. T7 Driver Cannulated AO (Part Number 110018531)
Product Usage:
The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis Terminated |
HWC | None listed |
| Mar 28, 2019 | Zimmer Biomet, Inc. T7 Driver Solid AO (Part Number 110018541)
Product Usage:
The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.