K252061
- 510(k) number
- K252061
- Device name
- Distal Xtremities System
- Applicant
- TriMed, Inc. CA · US
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2025-08-20
- Date received
- 2025-07-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K252061.pdf
Official FDA record: K252061
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.