510(k) K980288
Clearance Details
- Decision
- SN ()
- Decision Date
- July 29, 1998
- Date Received
- January 26, 1998
- Clearance Type
- Traditional
- 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