510(k) K234040 ยท HWC Screw, Fixation, Bone
TriMed Threaded Intramedullary Nail System
| Applicant | TriMed, Inc., Santa Clarita CA, US |
| Decision | Substantially Equivalent, Jan 18, 2024 |
| Received | Dec 21, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K234040
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2024 | TriMed Inc. TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only
TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3.6-65 T, Non Sterile, MD, Rx Only Open, Classified |
HWC | None listed |
| May 10, 2024 | TriMed Inc. TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only
TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3.6-65 T, Non Sterile, MD, Rx Only Open, Classified |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.