K252758
- 510(k) number
- K252758
- Device name
- Cannulated Screw and Kirschner (K wire) System
- Applicant
- Orthonovis, Inc. FL · US
- Product code
- HWC — Screw, Fixation, Bone
- Decision date
- 2025-10-02
- Date received
- 2025-08-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K252758.pdf
Official FDA record: K252758
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.