K260353
- 510(k) number
- K260353
- Device name
- Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button
- Applicant
- Arthrex, Inc. FL · US
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2026-03-03
- Date received
- 2026-02-03
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K260353.pdf
Official FDA record: K260353
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.