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FDA 510(k)

TRUSS THORACOLUMBAR PLATE SYSTEM

K-Number: K092108 · 2009-08-13

ApplicantGlobus Medical, Inc.
Decision Date2009-08-13
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRUSS 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 2009-08-13 under 510(k) number K092108. 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 TRUSS THORACOLUMBAR PLATE SYSTEM?

TRUSS THORACOLUMBAR PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2009-08-13. The listed applicant is Globus Medical, Inc.. The 510(k) number is K092108.

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

TRUSS THORACOLUMBAR PLATE SYSTEM received FDA 510(k) clearance on 2009-08-13, under 510(k) number K092108.

Who is the listed applicant for TRUSS 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 TRUSS THORACOLUMBAR PLATE SYSTEM?

The FDA product code for TRUSS 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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