K252254
- 510(k) number
- K252254
- Device name
- Osteotomy Wedge System
- Applicant
- Sinaptic Surgical UT · US
- Product code
- PLF — Bone Wedge
- Decision date
- 2025-10-17
- Date received
- 2025-07-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K252254.pdf
Official FDA record: K252254
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.