Clearance Summary
UNIVATION UNICONDYLAR KNEE SYSTEM received FDA 510(k) clearance under submission number K081293, sponsored by Aesculap Implant Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2008-09-22.
- Submission: K081293
- Applicant / Sponsor: Aesculap Implant Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3530
- Decision date: 2008-09-22
Classification & Regulation
This clearance is catalogued under FDA product code HRY and 21 CFR 888.3530, within the Orthopedic review panel as a Class II device.