Clearance Summary
Response Ortho Smart Fixator - Hexapod System received FDA 510(k) clearance under submission number K263083, sponsored by Response Ortho Solutions, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2026-10-02.
- Submission: K263083
- Applicant / Sponsor: Response Ortho Solutions, LLC
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2026-10-02
Classification & Regulation
This clearance is catalogued under FDA product code KTT and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.