510(k) K122959 ยท HWC Screw, Fixation, Bone
HAMMER TOE IMPLANT
| Applicant | Trilliant Surgical, Ltd., Round Rock TX, US |
| Decision | Substantially Equivalent, Nov 7, 2012 |
| Received | Sep 25, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122959
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 19, 2018 | Trilliant Surgical, LLC Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Two-Step Hammertoe Implant System, Model 214-00-001. The firm name on the label is Trilliant Surgical Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.