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FDA 510(k)

Gentrix Surgical Matrix

K-Number: K162554 · 2016-10-21

ApplicantAcell, Inc.
Decision Date2016-10-21
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Gentrix Surgical Matrix is a medical device manufactured by Acell, Inc.. It received FDA 510(k) clearance on 2016-10-21 under approval number K162554. 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?

Gentrix Surgical Matrix is a medical device that received FDA 510(k) clearance on 2016-10-21. It is manufactured by Acell, Inc.. The 510(k) number is K162554.

When was Gentrix Surgical Matrix approved by the FDA?

Gentrix Surgical Matrix received FDA 510(k) clearance on 2016-10-21, under approval number K162554.

What company makes Gentrix Surgical Matrix?

Gentrix Surgical Matrix is manufactured by Acell, Inc..

What is the FDA product code for Gentrix Surgical Matrix?

The FDA product code for Gentrix Surgical Matrix is FTM.

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Other Devices by Acell, Inc.

K153754MicroMatrix K172399MicroMatrix K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend K180776Cytal Wound Particulate K191734MatriStem UBM Pericardial Patch K192725Cytal Wound Matrix 3-Layer

View all 11 devices →

Related Devices (Code: FTM)

K162461Endoform Plastics and Reconstructive MatrixAroa Biosurgery (Formerly Mesynthes Limited) 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) K152206SurgiPure XD Reconstructive Tissue MatrixTissue Regenix Group Plc

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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