K250055
- 510(k) number
- K250055
- Device name
- BPS - Bone Fragment Fixation Plates, Screws and Washers
- Applicant
- Orthonovis, Inc. FL · US
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2025-02-06
- Date received
- 2025-01-10
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250055.pdf
Official FDA record: K250055
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.