510(k) clearance
Pediatric Nailing Platform Femur
- 510(k) number
- K261345
- Applicant
- OrthoPediatrics Corp.
- Decision date
- Sep 24, 2026
- Date received
- Apr 23, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- HSB
- Device type
- Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II
- Regulation
- 21 CFR 888.3020
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Warsaw, IN, US