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FDA 510(k)

Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend

K-Number: K170763 · 2017-06-08

ApplicantAcell, Inc.
Decision Date2017-06-08
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend is a medical device manufactured by Acell, Inc.. It received FDA 510(k) clearance on 2017-06-08 under approval number K170763. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend?

Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend is a medical device that received FDA 510(k) clearance on 2017-06-08. It is manufactured by Acell, Inc.. The 510(k) number is K170763.

When was Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend approved by the FDA?

Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend received FDA 510(k) clearance on 2017-06-08, under approval number K170763.

What company makes Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend?

Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend is manufactured by Acell, Inc..

What is the FDA product code for Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend?

The FDA product code for Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend is FTM.

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Other Devices by Acell, Inc.

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Related Devices (Code: FTM)

K162461Endoform Plastics and Reconstructive MatrixAroa Biosurgery (Formerly Mesynthes Limited) K162554Gentrix Surgical MatrixAcell, Inc. K160181COLORADO THERAPEUTICS XENOGRAFT IMPLANTColorado Therapeutics, LLC K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugCook Biotech Incorporated K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated K153633Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)

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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