Clearance Summary
ACTIVE UNICOMPARTMENTAL KNEE SYSTEM received FDA 510(k) clearance under submission number K060412, sponsored by Australian Surgical Design & Manufacture. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2006-05-17.
- Submission: K060412
- Applicant / Sponsor: Australian Surgical Design & Manufacture
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3530
- Decision date: 2006-05-17
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.