K251296
- 510(k) number
- K251296
- Device name
- The Acumed Wrist Fixation System
- Applicant
- Acumed, LLC OR · US
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2025-06-18
- Date received
- 2025-04-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K251296.pdf
Official FDA record: K251296
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.