K250929

TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm)

510(k) number: K250929
Device name: TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm)
Applicant: TriMed, Inc. CA · US
Product code: HRS — Plate, Fixation, Bone
Decision date: 2025-06-26
Date received: 2025-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Orthopedic

PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain

Also available from FDA: K250929.pdf

Official FDA record: K250929

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.