FDA 510(k)

DuraGen Secure Dural Regeneration Matrix

K-Number: K163456 · 2017-01-06

ApplicantIntegra LifeSciences Corporation

Decision Date2017-01-06

Product CodeGXQ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

DuraGen Secure Dural Regeneration Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2017-01-06 under 510(k) number K163456. The device is classified under product code GXQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DuraGen Secure Dural Regeneration Matrix?

DuraGen Secure Dural Regeneration Matrix is a medical device that received FDA 510(k) clearance on 2017-01-06. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K163456.

When did DuraGen Secure Dural Regeneration Matrix receive FDA 510(k) clearance?

DuraGen Secure Dural Regeneration Matrix received FDA 510(k) clearance on 2017-01-06, under 510(k) number K163456.

Who is the listed applicant for DuraGen Secure Dural Regeneration Matrix?

The FDA 510(k) record lists Integra LifeSciences Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DuraGen Secure Dural Regeneration Matrix?

The FDA product code for DuraGen Secure Dural Regeneration Matrix is GXQ.

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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.