K252625
- 510(k) number
- K252625
- Device name
- The Response Ortho Smart Fixator - Hexapod System
- Applicant
- Response Ortho Solutions, LLC FL · US
- Product code
- KTT — Appliance, Fixation, Nail/Blade/Plate Combination, M
- Decision date
- 2025-11-20
- Date received
- 2025-08-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K252625.pdf
Official FDA record: K252625
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.