510(k) K212428
K212428 is an FDA 510(k) premarket notification submitted by Medtronic Sofamor Danek for the device "Centerpiece Plate Fixation System". The FDA issued a decision of Substantially Equivalent on December 13, 2021. The device falls under product code NQW (Orthosis, Spine, Plate, Laminoplasty, Metal), a Class II device regulated under 21 CFR 888.3050. Medtronic Sofamor Danek has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 2021
- Date Received
- August 4, 2021
- Clearance Type
- Traditional
- 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.