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FDA 510(k)

Bovine Dermis Collagen Dermal Matrix

K-Number: K243071 · 2024-12-19

ApplicantCollagen Matrix, Inc.
Decision Date2024-12-19
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Bovine Dermis Collagen Dermal Matrix is a medical device manufactured by Collagen Matrix, Inc.. It received FDA 510(k) clearance on 2024-12-19 under approval number K243071. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bovine Dermis Collagen Dermal Matrix?

Bovine Dermis Collagen Dermal Matrix is a medical device that received FDA 510(k) clearance on 2024-12-19. It is manufactured by Collagen Matrix, Inc.. The 510(k) number is K243071.

When was Bovine Dermis Collagen Dermal Matrix approved by the FDA?

Bovine Dermis Collagen Dermal Matrix received FDA 510(k) clearance on 2024-12-19, under approval number K243071.

What company makes Bovine Dermis Collagen Dermal Matrix?

Bovine Dermis Collagen Dermal Matrix is manufactured by Collagen Matrix, Inc..

What is the FDA product code for Bovine Dermis Collagen Dermal Matrix?

The FDA product code for Bovine Dermis Collagen Dermal Matrix is KGN.

Related Clinical Trials

NCT06915402 Efficacy and Safety of "LMW - CL - HA - FACE/BODY" for the Augmentation of the Cheeks COMPLETED NCT07613775 Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions NOT_YET_RECRUITING NCT06335628 Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix RECRUITING NCT05945329 Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation RECRUITING NCT07473674 This Study Evaluates Skin Response Following Application of a Collagen-based Material in Healthy Adult Volunteers Using a Standardized Skin Prick Test. Skin Responses Will be Assessed at Multiple Time Points Following Application, and the Study is Intended to Evaluate Dermal Safety. COMPLETED NCT07185191 Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS) RECRUITING

Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026)

Other Devices by Collagen Matrix, Inc.

K152600Collagen Dental Wound Dressings K171008Anorganic Bone Mineral with Collagen in Delivery Applicator K170541Anorganic Bone Mineral in Delivery Applicator K170656Reinforced Flexible Collagen Nerve Cuff K162158Porcine Anorganic Bone Mineral in Delivery Applicator K182074Mineral Collagen Composite Bioactive Moldable

View all 16 devices →

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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