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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 the device name listed in this FDA 510(k) record. The listed applicant is Novabone Products, LLC. It received FDA 510(k) clearance on 2023-06-09 under 510(k) 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. The listed applicant is Novabone Products, LLC. The 510(k) number is K220498.

When did NovoGen Wound Matrix receive FDA 510(k) clearance?

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

Who is the listed applicant for NovoGen Wound Matrix?

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

What is the FDA product code for NovoGen Wound Matrix?

The FDA product code for NovoGen Wound Matrix is KGN.

Other records listing Novabone Products, LLC 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.

K242299NovaBone Putty - Synthetic Bioactive Bone GraftK240404NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)K163310NovaBone IRM

Related Devices (Code: KGN)

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.

K260596Collagen Wound PowderVentris MedicalK260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.K254034Roosin Collagen PowderRoosin Medical Co., Ltd.K253974Roosin Collagen DressingRoosin Medical Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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