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FDA 510(k)

GATEWAY THORACOLUMBAR PLATE SYSTEM

K-Number: K062407 · 2006-09-06

ApplicantGlobus Medical, Inc.
Decision Date2006-09-06
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GATEWAY THORACOLUMBAR PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2006-09-06 under 510(k) number K062407. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GATEWAY THORACOLUMBAR PLATE SYSTEM?

GATEWAY THORACOLUMBAR PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2006-09-06. The listed applicant is Globus Medical, Inc.. The 510(k) number is K062407.

When did GATEWAY THORACOLUMBAR PLATE SYSTEM receive FDA 510(k) clearance?

GATEWAY THORACOLUMBAR PLATE SYSTEM received FDA 510(k) clearance on 2006-09-06, under 510(k) number K062407.

Who is the listed applicant for GATEWAY THORACOLUMBAR PLATE SYSTEM?

The FDA 510(k) record lists Globus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GATEWAY THORACOLUMBAR PLATE SYSTEM?

The FDA product code for GATEWAY THORACOLUMBAR PLATE SYSTEM is KWQ.

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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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