510(k) K031751 ยท HWC Screw, Fixation, Bone
RAPIDFIRE SELF DRILLING SCREWS
| Applicant | Walter Lorenz Surgical, Inc., Jacksonville FL, US |
| Decision | Substantially Equivalent, Jun 26, 2003 |
| Received | Jun 5, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031751
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2020 | Biomet, Inc. RapidFire Clip, Item Number 95-0154 - Product Usage:
Fixation of Craniofacial bone. Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.