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FDA 510(k)

NeoMatriX Wound Matrix

K-Number: K181330 · 2018-10-11

ApplicantNextgen Biologics, Inc.
Decision Date2018-10-11
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

NeoMatriX Wound Matrix is a medical device manufactured by Nextgen Biologics, Inc.. It received FDA 510(k) clearance on 2018-10-11 under approval number K181330. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeoMatriX Wound Matrix?

NeoMatriX Wound Matrix is a medical device that received FDA 510(k) clearance on 2018-10-11. It is manufactured by Nextgen Biologics, Inc.. The 510(k) number is K181330.

When was NeoMatriX Wound Matrix approved by the FDA?

NeoMatriX Wound Matrix received FDA 510(k) clearance on 2018-10-11, under approval number K181330.

What company makes NeoMatriX Wound Matrix?

NeoMatriX Wound Matrix is manufactured by Nextgen Biologics, Inc..

What is the FDA product code for NeoMatriX Wound Matrix?

The FDA product code for NeoMatriX Wound Matrix is KGN.

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Other Devices by Nextgen Biologics, Inc.

K210024NeoMatriX Wound Matrix

Related Devices (Code: KGN)

K160136Flowable Wound MatrixCook Biotech Incorporated K152600Collagen Dental Wound DressingsCollagen Matrix, Inc. K153754MicroMatrixAcell, Inc. K153690PriMatrix Dermal Repair ScaffoldTei Biosciences, Inc. K172010gel-e BandageGel-E, Inc. (Formerly Remedium Technologies, Inc.) K171842Geistlich Wound MatrixGeistlich Pharma AG

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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