TriMed Threaded Intramedullary Nail System— 510(k) K234040
Substantially EquivalentTriMed, Inc.
FDA 510(k) clearance K234040 for TriMed Threaded Intramedullary Nail System, Substantially Equivalent on 2024-01-18. Applicant: TriMed, Inc.. Device class: 2.
Clearance details
- Applicant
- TriMed, Inc.
- Product code
- Code HWC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Santa Clarita, CA, US
Recent devices under product code HWC
view allMore clearances from TriMed, Inc.
view allAdverse events under product code HWC
product code HWC- Death
- 20
- Injury
- 15,910
- Malfunction
- 8,192
- Other
- 1
- Total
- 24,123
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K234040
K-number listed on FDA's recall record- Z-1791-2024 — 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
- Z-1792-2024 — 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
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K234040.
Data sourced from openFDA. This site is unofficial and independent of the FDA.