510(k) Report

Devices descending from K060952

22 later devices reach Collagen Nerve Wrap through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233322Mochida Nerve CuffMochida Pharmaceutical Co., Ltd.20240—
+1K103081Covaortho-Nerve Resorbable Collagen MembraneBiom'Up Sas20123—
+1K100382Salutunnel Nerve Protector, Model ED-20329, ED-20330, ED-20331Salumedica, LLC20100—
+1K080452Collagen Tendon WrapCollagen Matrix, Inc.200815—
+2K190246NeuroShieldMonarch Bioimplants GmbH20190—
+2K152967NerbridgeToyobo Co., Ltd.20161—
+2K130428CovameshBiomup S.A.20130—
+2K112423Collagen Tendon SheetRotation Medical, Inc.201114—
+3K223538Integrity ImplantAnika Therapeutics, Inc.20231—
+3K201572TAPESTRY Biointegrative ImplantEmbody, Inc.20205—
+3K122048Collagen Tendon Sheet-DRotation Medical, Inc.20135—
+4K250997Integrity™ ImplantAnika Therapeutics, Inc.20250—
+4K250021RotiumNanofiber Solutions, LLC20250—
+4K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+4K212306Tapestry Biointegrative ImplantEmbody, Inc.20212—
+4K140300Collagen Tendon Sheet-Ddi (CTS-Ddi)Rotation Medical, Inc.20144—
+5K252647Tapestry Biointegrative ImplantEmbody, Inc.20250—
+5K222501Regeneten Bioinductive ImplantSmith and Nephew, Inc.20233—
+5K220867Tapestry Biointegrative ImplantEmbody, Inc.20220—
+6K242187BioBrace®Conmed Corporation20241—
+6K242631REGENETEN™ Bioinductive ImplantSmith & Nephew Inc., Endoscopy Div.20240—
+7K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—