510(k) Report

Devices descending from K032673

26 later devices reach Immix Plastifilm through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082—
+1K042811Vivosorb Sheet, Model FS01Polyganics B.V.,200422—
+2K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC20171—
+2K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+2K062558Mesosfol Surgical FilmBiomet Manufacturing Corp200721—
+3K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+3K112567Biomerix AssureBiomerix Corporation20110—
+3K090160Suprathel Wound and Burn DressingPolymedics Innovations, GmbH200918—
+4K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+4K170213SupraSDRM Biodegradable Matrix Wound DressingPolymedics Innovations, GmbH20170—
+4K142879BTM Wound DressingPolynovo Biomaterials Pty, Ltd.20155—
+4K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+5K172140NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm)…Polynovo Biomaterials Pty, Ltd.20174—
+5K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+5K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+6K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+6K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+6K251567NovoSorb BTMPolynovo Biomaterials Pty, Ltd.20250—
+6K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+6K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+6K222189SiOxD Wound MatrixSioxmed, LLC20222—
+6K193583Restrata®Acera Surgical, Inc.202011
+7K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+7K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+7K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+7K232847SiOxD Wound MatrixSioxmed, LLC20231—