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FDA 510(k)

HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System

K-Number: K171413 · 2017-07-14

ApplicantGlobus Medical, Inc.
Decision Date2017-07-14
Product CodeNQW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2017-07-14 under approval number K171413. The device is classified under product code NQW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System?

HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System is a medical device that received FDA 510(k) clearance on 2017-07-14. It is manufactured by Globus Medical, Inc.. The 510(k) number is K171413.

When was HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System approved by the FDA?

HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System received FDA 510(k) clearance on 2017-07-14, under approval number K171413.

What company makes HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System?

HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System is manufactured by Globus Medical, Inc..

What is the FDA product code for HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System?

The FDA product code for HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System is NQW.

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Related Devices (Code: NQW)

K160114Xspan Laminoplasty Fixation SystemX-Spine Systems, Inc. K153735Release Laminoplasty Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) K181717Life Spine Laminoplasty SystemLife Spine, Inc. K173215Choice Spine Laminoplasty™ Fixation SystemChoicespine, LP K191927Hinged Laminoplasty SystemLife Spine, Inc. K191169NuVasive® Camber Laminoplasty SystemNu Vasive, Incorporated

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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