K250623
- 510(k) number
- K250623
- Device name
- Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur
- Applicant
- OrthoPediatrics Corp. IN · US
- Product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Decision date
- 2025-04-01
- Date received
- 2025-03-03
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K250623.pdf
Official FDA record: K250623
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.