510(k) K240173 ยท HRS Plate, Fixation, Bone
Treace Medical Systems (TMC) Plating System
| Applicant | Treace Medical Concepts, Inc., Ponte Vedra FL, US |
| Decision | Substantially Equivalent, Feb 22, 2024 |
| Received | Jan 23, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K240173
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 23, 2024 | Treace Medical Concepts, Inc. Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component. Open, Classified |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.