510(k) K073233
K073233 is an FDA 510(k) premarket notification submitted by Advanced Bio-Surfaces, Inc. for the device "ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on January 28, 2008. The device falls under product code HSH (Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)), a Class II device regulated under 21 CFR 888.3590. Advanced Bio-Surfaces, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 28, 2008
- Date Received
- November 15, 2007
- 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