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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 the device name listed in this FDA 510(k) record. The listed applicant is Acell, Inc.. It received FDA 510(k) clearance on 2017-06-08 under 510(k) 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. The listed applicant is Acell, Inc.. The 510(k) number is K170763.

When did Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend receive FDA 510(k) clearance?

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

Who is the listed applicant for Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend?

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

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.

Other records listing Acell, Inc. 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.

K241724Cytal® Wound Matrix; Cytal® Burn MatrixK241706MicroMatrix® UBM ParticulateK230980MicroMatrix® FlexK191734MatriStem UBM Pericardial PatchK192725Cytal Wound Matrix 3-LayerK182259Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal

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Related Devices (Code: FTM)

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.

K262406EluPro Antibiotic-Eluting BioEnvelopeBoston ScientificK250598Endoform Reconstructive Template - PLGAAroa Biosurgery , Ltd.K243595OviTex PRS (Long-Term Resorbable)TELA Bio, Inc.K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.K241126OviTex PRSTELA Bio, Inc.K223052Peri-Guard and Supple Peri-GuardSynovis Life Technologies, 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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