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FDA 510(k)

LIFECELL DURAL SUBSTITUTE MATRIX

K-Number: K061208 · 2007-01-03

ApplicantLifecell Corp.
Decision Date2007-01-03
Product CodeGXQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LIFECELL DURAL SUBSTITUTE MATRIX is the device name listed in this FDA 510(k) record. The listed applicant is Lifecell Corp.. It received FDA 510(k) clearance on 2007-01-03 under 510(k) number K061208. 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 LIFECELL DURAL SUBSTITUTE MATRIX?

LIFECELL DURAL SUBSTITUTE MATRIX is a medical device that received FDA 510(k) clearance on 2007-01-03. The listed applicant is Lifecell Corp.. The 510(k) number is K061208.

When did LIFECELL DURAL SUBSTITUTE MATRIX receive FDA 510(k) clearance?

LIFECELL DURAL SUBSTITUTE MATRIX received FDA 510(k) clearance on 2007-01-03, under 510(k) number K061208.

Who is the listed applicant for LIFECELL DURAL SUBSTITUTE MATRIX?

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

What is the FDA product code for LIFECELL DURAL SUBSTITUTE MATRIX?

The FDA product code for LIFECELL DURAL SUBSTITUTE MATRIX is GXQ.

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Other records listing Lifecell Corp. as applicant

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.

K130817LTN - LAPAROSCOPIC SURGICAL MESHK112534LIFECELL TISSUE EXPANDERK121289LTM-LABAROSCOPIC SURGICAL MESHK082176LTM-BPS SURGICAL MESHK082103LTM WOUND DRESSINGK080353LTM-T SURGICAL MESH

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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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