K261145
- 510(k) number
- K261145
- Device name
- Avanti Distal Elbow ORIF System
- Applicant
- Avanti Orthopaedics, LLC DE · US
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2026-05-09
- Date received
- 2026-04-07
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K261145.pdf
Official FDA record: K261145
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.