K260090
- 510(k) number
- K260090
- Device name
- SMART Osteotomy System
- Applicant
- Actis Medical Pty., Ltd. AU
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2026-04-10
- Date received
- 2026-01-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K260090.pdf
Official FDA record: K260090
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.