K251132
- 510(k) number
- K251132
- Device name
- The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws
- Applicant
- Acumed, LLC OR · US
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2025-07-14
- Date received
- 2025-04-11
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K251132.pdf
Official FDA record: K251132
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.