K242343
- 510(k) number
- K242343
- Device name
- BPS Wrist Fracture System
- Applicant
- Orthonovis, Inc. FL · US
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2024-10-04
- Date received
- 2024-08-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K242343.pdf
Official FDA record: K242343
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.