Clearance Summary
R-X-FIX EXTERNAL FIXATOR received FDA 510(k) clearance under submission number K051017, sponsored by R-X-Fix. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2005-06-29.
- Submission: K051017
- Applicant / Sponsor: R-X-Fix
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2005-06-29
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.