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FDA 510(k)

DURAGEN II DURAL REGENERATION MATRIX

K-Number: K043427 · 2005-01-12

ApplicantIntegra Lifesciences Corp.
Decision Date2005-01-12
Product CodeGXQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DURAGEN II DURAL REGENERATION MATRIX is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Corp.. It received FDA 510(k) clearance on 2005-01-12 under 510(k) number K043427. 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 II DURAL REGENERATION MATRIX?

DURAGEN II DURAL REGENERATION MATRIX is a medical device that received FDA 510(k) clearance on 2005-01-12. The listed applicant is Integra Lifesciences Corp.. The 510(k) number is K043427.

When did DURAGEN II DURAL REGENERATION MATRIX receive FDA 510(k) clearance?

DURAGEN II DURAL REGENERATION MATRIX received FDA 510(k) clearance on 2005-01-12, under 510(k) number K043427.

Who is the listed applicant for DURAGEN II DURAL REGENERATION MATRIX?

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

What is the FDA product code for DURAGEN II DURAL REGENERATION MATRIX?

The FDA product code for DURAGEN II DURAL REGENERATION MATRIX is GXQ.

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Related Devices (Code: GXQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251191Collagen Dura Regeneration Membrane - RepairCollagen Matrix, Inc.K250420Helios Dura Regeneration MatrixHelios Biomedical, Inc.K223445ArtiFasciaNurami Medical , Ltd.K212943SyntheCel Dura RepairSynthes (USA) Products, LLCK183513XenoSure Dura Biologic PatchLeMaitre Vascular, Inc.K172603Cerafix Dura SubstituteAcera Surgical, Inc.

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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