K251362
- 510(k) number
- K251362
- Device name
- PediFlex Flexible Nail System
- Applicant
- OrthoPediatrics Corp. IN · US
- Product code
- HTY — Pin, Fixation, Smooth
- Decision date
- 2025-06-24
- Date received
- 2025-05-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K251362.pdf
Official FDA record: K251362
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.