510(k) K023804
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 2003
- Date Received
- November 14, 2002
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Fixation, Spinal Interlaminal
- Device Class
- Class II
- Regulation Number
- 888.3050
- Review Panel
- OR
- Submission Type