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510(k) K171413

HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System by Globus Medical, Inc. — Product Code NQW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2017
Date Received
May 15, 2017
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.

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