Clearance Summary
ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056 received FDA 510(k) clearance under submission number K053094, 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 2006-02-06.
- Submission: K053094
- Applicant / Sponsor: Advanced Bio-Surfaces, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3590
- Decision date: 2006-02-06
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.