510(k) Report

Devices descending from K012814

37 later devices reach Collagen Nerve Cuff through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233322Mochida Nerve CuffMochida Pharmaceutical Co., Ltd.20240—
+1K131541Flexible Cooagen Nerve CuffCollagen Matrix, Inc.20142—
+1K060952Collagen Nerve WrapCollagen Matrix, Inc.200622—
+1K031069Surgisis Nerve CuffCook Biotech, Inc.200310—
+2K170656Reinforced Flexible Collagen Nerve CuffCollagen Matrix, Inc.20170—
+2K162741AxoGuard Nerve ConnectorCook Biotech Incorporated20162—
+2K152684Nerve Capping DevicePolyganics Innovations BV20160—
+2K130557Neuragen 3DIntegra LifeSciences Corporation20141—
+2K132660Nerve CuffCook Biotech Incorporated20146—
+2K103081Covaortho-Nerve Resorbable Collagen MembraneBiom'Up Sas20123—
+2K100382Salutunnel Nerve Protector, Model ED-20329, ED-20330, ED-20331Salumedica, LLC20100—
+2K080452Collagen Tendon WrapCollagen Matrix, Inc.200815—
+3K223640Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard…Axogen Corporation20232—
+3K210665Nerve TapeBiocircuit Technologies, Incorporated20221—
+3K202234NervAlign Nerve CuffRenerve, Ltd.20220—
+3K190246NeuroShieldMonarch Bioimplants GmbH20190—
+3K163457NeuraGen 3D Nerve Guide MatrixIntegra LifeSciences Corporation20170—
+3K152967NerbridgeToyobo Co., Ltd.20161—
+3K130428CovameshBiomup S.A.20130—
+3K112423Collagen Tendon SheetRotation Medical, Inc.201114—
+4K242113Nerve Wrap (07-DW-001-TAB)Biocircuit Technologies, Inc.20250—
+4K233533NerveTapeBiocircuit Technologies, Inc.20240—
+4K231708Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard…Axogen Corporation20230—
+4K223538Integrity ImplantAnika Therapeutics, Inc.20231—
+4K201572TAPESTRY Biointegrative ImplantEmbody, Inc.20205—
+4K122048Collagen Tendon Sheet-DRotation Medical, Inc.20135—
+5K250997Integrity™ ImplantAnika Therapeutics, Inc.20250—
+5K250021RotiumNanofiber Solutions, LLC20250—
+5K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+5K212306Tapestry Biointegrative ImplantEmbody, Inc.20212—
+5K140300Collagen Tendon Sheet-Ddi (CTS-Ddi)Rotation Medical, Inc.20144—
+6K252647Tapestry Biointegrative ImplantEmbody, Inc.20250—
+6K222501Regeneten Bioinductive ImplantSmith and Nephew, Inc.20233—
+6K220867Tapestry Biointegrative ImplantEmbody, Inc.20220—
+7K242187BioBrace®Conmed Corporation20241—
+7K242631REGENETEN™ Bioinductive ImplantSmith & Nephew Inc., Endoscopy Div.20240—
+8K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—