510(k) K053094
ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056 by
Advanced Bio-Surfaces, Inc.
— Product Code HSH
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 6, 2006
- Date Received
- November 3, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
- Device Class
- Class II
- Regulation Number
- 888.3590
- Review Panel
- OR
- Submission Type