510(k) Report

Devices descending from K011168

46 later devices reach Neurogen Nerve Guide through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253363NeuroSpan BridgeAuxilium Biotechnologies, Inc.20260—
+1K180222Reaxon PlusMedovent GmbH20180—
+1K143711Reaxon PlusMedovent GmbH20151—
+1K130557Neuragen 3DIntegra LifeSciences Corporation20141—
+1K103081Covaortho-Nerve Resorbable Collagen MembraneBiom'Up Sas20123—
+1K050573Neurolac Nerve GuidePolyganics B.V.,20052—
+1K032115Neurolac Nerve Guide Models NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03Polyganics B.V.,20035—
+1K031069Surgisis Nerve CuffCook Biotech, Inc.200310—
+1K012814Collagen Nerve CuffCollagen Matrix, Inc.200137—
+2K233322Mochida Nerve CuffMochida Pharmaceutical Co., Ltd.20240—
+2K230794Rebuilder Nerve Guidance ConduitCelestray Biotech Company, LLC.,20240—
+2K190246NeuroShieldMonarch Bioimplants GmbH20190—
+2K163457NeuraGen 3D Nerve Guide MatrixIntegra LifeSciences Corporation20170—
+2K162741AxoGuard Nerve ConnectorCook Biotech Incorporated20162—
+2K152967NerbridgeToyobo Co., Ltd.20161—
+2K152684Nerve Capping DevicePolyganics Innovations BV20160—
+2K131541Flexible Cooagen Nerve CuffCollagen Matrix, Inc.20142—
+2K132660Nerve CuffCook Biotech Incorporated20146—
+2K130428CovameshBiomup S.A.20130—
+2K112267Neurolac (R) Nerve GuidePolyganics B.V.,20113—
+2K060952Collagen Nerve WrapCollagen Matrix, Inc.200622—
+3K260245SILKBridgeKLISBio S.r.l.20260—
+3K223640Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard…Axogen Corporation20232—
+3K210665Nerve TapeBiocircuit Technologies, Incorporated20221—
+3K202234NervAlign Nerve CuffRenerve, Ltd.20220—
+3K170656Reinforced Flexible Collagen Nerve CuffCollagen Matrix, Inc.20170—
+3K100382Salutunnel Nerve Protector, Model ED-20329, ED-20330, ED-20331Salumedica, LLC20100—
+3K080452Collagen Tendon WrapCollagen Matrix, Inc.200815—
+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—
+4K112423Collagen Tendon SheetRotation Medical, Inc.201114—
+5K223538Integrity ImplantAnika Therapeutics, Inc.20231—
+5K201572TAPESTRY Biointegrative ImplantEmbody, Inc.20205—
+5K122048Collagen Tendon Sheet-DRotation Medical, Inc.20135—
+6K250997Integrity™ ImplantAnika Therapeutics, Inc.20250—
+6K250021RotiumNanofiber Solutions, LLC20250—
+6K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+6K212306Tapestry Biointegrative ImplantEmbody, Inc.20212—
+6K140300Collagen Tendon Sheet-Ddi (CTS-Ddi)Rotation Medical, Inc.20144—
+7K252647Tapestry Biointegrative ImplantEmbody, Inc.20250—
+7K222501Regeneten Bioinductive ImplantSmith and Nephew, Inc.20233—
+7K220867Tapestry Biointegrative ImplantEmbody, Inc.20220—
+8K242187BioBrace®Conmed Corporation20241—
+8K242631REGENETEN™ Bioinductive ImplantSmith & Nephew Inc., Endoscopy Div.20240—
+9K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—