Clearance Summary
ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS received FDA 510(k) clearance under submission number K073233, sponsored by Advanced Bio-Surfaces, 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 2008-01-28.
- Submission: K073233
- Applicant / Sponsor: Advanced Bio-Surfaces, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3590
- Decision date: 2008-01-28
Classification & Regulation
This clearance is catalogued under FDA product code HSH and 21 CFR 888.3590, within the Orthopedic review panel as a Class II device.