HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System

Orthosis, Spine, Plate, Laminoplasty, Metal

Globus Medical Inc.

The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Haven™ Laminoplasty System, Canopy® Laminoplasty Fixation System.

Pre-market Notification Details

• Device ID: K171413
• 510k Number: K171413
• Device Name: HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System
• Classification: Orthosis, Spine, Plate, Laminoplasty, Metal
• Applicant: Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403
• Contact: Kelly J. Baker
• Correspondent: Kelly J. Baker, Ph.d.; Globus Medical Inc. 2560 General Armistead Avenue Audubon, PA 19403
• Product Code: NQW
• CFR Regulation Number: 888.3050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-05-15
• Decision Date: 2017-07-14
• Summary: summary