510(k) Report

Devices descending from K071425

25 later devices reach Unite Biomatrix through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122502Bridge Extracellular Collegen MatrixHarbor Medtech, Inc.20131—
+1K112399Unite BiomatrixSynovis Orthopedic & Woundcare20110—
+1K092096Endoform Dermal TemplateMesynthes, Ltd.2010193
+1K082103LTM Wound DressingLifecell Corp.20087—
+2K260669Endoform Dermal TemplateAroa Biosurgery, Ltd.20260—
+2K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+2K200502Myriad ParticlesAroa Biosurgery, Ltd.20214—
+2K171231Endoform Topical MatrixAroa Biosurgery20173—
+2K140367Architect PX Extracellular Collagen MatrixHarbor Medtech, Inc.20140—
+2K132343Marigen Wound DressingKerecis Limited20135—
+2K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+2K101546Endoform Dental TemplateMesynthes, Ltd.20100—
+3K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials20260—
+3K231325Corplex P / Theracor P / Allacor PStimlabs, LLC20243—
+3K200413SymphonyAroa Biosurgery, Ltd.20202—
+3K190528MariGen Wound ExtraKerecis Limited20193—
+3K153364Kerecis SecureMeshKerecis Limited20160—
+4K253204CatalyzeBioTissue Holdings, Inc.20260—
+4K252673LacertaMatrixLacerta Life Science20251—
+4K253339TheracorStimlabs, LLC20250—
+4K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+4K242828Corplex P/ Theracor P/ Allacor PStimlabs, LLC20240—
+4K241080Kerecis Parvus (50207)Kerecis Limited20241—
+4K213231Kerecis SiliconeKerecis Limited20221—
+5K260218LacertaMatrixLacerta Life Sciences20260—