510(k) clearance
Response Ortho Smart Fixator - Hexapod System
- 510(k) number
- K263083
- Applicant
- Response Ortho Solutions, LLC
- Decision date
- Oct 2, 2026
- Date received
- Sep 2, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- KTT
- Device type
- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device class
- Class II
- Regulation
- 21 CFR 888.3030
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Boynton Beach, FL, US