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FDA 510(k)

FortiShield (Biosynthetic Wound Matrix)

K-Number: K212579 · 2023-05-02

ApplicantOrganogenesis, Inc.
Decision Date2023-05-02
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

FortiShield (Biosynthetic Wound Matrix) is the device name listed in this FDA 510(k) record. The listed applicant is Organogenesis, Inc.. It received FDA 510(k) clearance on 2023-05-02 under 510(k) number K212579. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FortiShield (Biosynthetic Wound Matrix)?

FortiShield (Biosynthetic Wound Matrix) is a medical device that received FDA 510(k) clearance on 2023-05-02. The listed applicant is Organogenesis, Inc.. The 510(k) number is K212579.

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

FortiShield (Biosynthetic Wound Matrix) received FDA 510(k) clearance on 2023-05-02, under 510(k) number K212579.

Who is the listed applicant for FortiShield (Biosynthetic Wound Matrix)?

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

What is the FDA product code for FortiShield (Biosynthetic Wound Matrix)?

The FDA product code for FortiShield (Biosynthetic Wound Matrix) is KGN.

Other records listing Organogenesis, 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.

K220317PuraPly Micronized Wound Matrix (PuraPly MZ)

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

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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