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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 a medical device manufactured by Organogenesis, Inc.. It received FDA 510(k) clearance on 2023-05-02 under approval 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. It is manufactured by Organogenesis, Inc.. The 510(k) number is K212579.

When was FortiShield (Biosynthetic Wound Matrix) approved by the FDA?

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

What company makes FortiShield (Biosynthetic Wound Matrix)?

FortiShield (Biosynthetic Wound Matrix) is manufactured by Organogenesis, Inc..

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

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

Related Clinical Trials

NCT07613775 Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions NOT_YET_RECRUITING NCT07316192 Pelashield™ PainGuard™ vs Restrata® in HS Surgery RECRUITING NCT06073808 The Role of Amnion Membrane Allografts in Nipple Preservation NOT_YET_RECRUITING NCT06919809 Effectiveness and Safety of X A-DERM™ Microsurfaced Acellular Dermal Matrix for Wound Healing After MOHS Surgery COMPLETED NCT07546279 The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects. RECRUITING NCT06857708 The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix® RECRUITING

Other Devices by Organogenesis, Inc.

K220317PuraPly Micronized Wound Matrix (PuraPly MZ)

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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