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FDA 510(k)

NovoGen Wound Matrix

K-Number: K220498 · 2023-06-09

ApplicantNovabone Products, LLC
Decision Date2023-06-09
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

NovoGen Wound Matrix is a medical device manufactured by Novabone Products, LLC. It received FDA 510(k) clearance on 2023-06-09 under approval number K220498. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NovoGen Wound Matrix?

NovoGen Wound Matrix is a medical device that received FDA 510(k) clearance on 2023-06-09. It is manufactured by Novabone Products, LLC. The 510(k) number is K220498.

When was NovoGen Wound Matrix approved by the FDA?

NovoGen Wound Matrix received FDA 510(k) clearance on 2023-06-09, under approval number K220498.

What company makes NovoGen Wound Matrix?

NovoGen Wound Matrix is manufactured by Novabone Products, LLC.

What is the FDA product code for NovoGen Wound Matrix?

The FDA product code for NovoGen Wound Matrix is KGN.

Related Clinical Trials

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Other Devices by Novabone Products, LLC

K163310NovaBone IRM K242299NovaBone Putty - Synthetic Bioactive Bone Graft K240404NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)

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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