Clearance Summary
AEON-C Stand Alone System received FDA 510(k) clearance under submission number K191477, sponsored by Huvexel Co. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2019-11-13.
- Submission: K191477
- Applicant / Sponsor: Huvexel Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2019-11-13
Classification & Regulation
This clearance is catalogued under FDA product code OVE and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.