Clearance Summary
AXIA RADIAL HEAD SYSTEM received FDA 510(k) clearance under submission number K132735, sponsored by Imds (Innovative MEdical Device Systems) - Leis ME. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2014-01-07.
- Submission: K132735
- Applicant / Sponsor: Imds (Innovative MEdical Device Systems) - Leis ME
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3170
- Decision date: 2014-01-07
Classification & Regulation
This clearance is catalogued under FDA product code KWI and 21 CFR 888.3170, within the Orthopedic review panel as a Class II device.