510(k) K150469
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 2015
- Date Received
- February 23, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Spine, Plate, Laminoplasty, Metal
- Device Class
- Class II
- Regulation Number
- 888.3050
- Review Panel
- OR
- Submission Type
This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.