510(k) K121732
K121732 is an FDA 510(k) premarket notification submitted by Globus Medical, Inc. for the device "CANOPY LAMINOPLASTY FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 31, 2012. The device falls under product code NQW (Orthosis, Spine, Plate, Laminoplasty, Metal), a Class II device regulated under 21 CFR 888.3050. Globus Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 2012
- Date Received
- June 13, 2012
- 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.