510(k) Report

Devices descending from K081917

1,008 later devices reach Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+1K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+1K173148ACIFColigne AG20171—
+1K170890TELIX K Interbody SystemBiedermann Motech GmbH & Co. KG20170—
+1K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+1K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+1K151352CONCORDE Bullet Spinal SystemMedos International SARL20153—
+1K150847Foundation Interbody DevicesCorelink, LLC201529—
+1K140759Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar…Medos International SARL2014204—
+1K140066Infill CervicalPinnacle Spine Group, LLC20140—
+1K133321Alamo CAlliance Partners, LLC20143—
+1K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+1K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+1K131671MectalifMedacta International201322—
+1K122639Synthes Syncage Evolution SpacerSynthes (USA) Products, LLC2013143—
+1K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+1K120517Depuy Pulse Cervical Cage SystemMedos International SARL20123—
+1K112696Twin Peaks Lumbar CageQualgenix, LLC20120—
+1K120024Mectalif TransforaminalMedacta International S.A.201223—
+1K112862Mecta-CMedacta International201114—
+1K113348Cougar SystemJohnson & Johnson2011591—
+1K111119Trabecular Metal (TM) Fusion DeviceZimmer Spine, Inc.201152—
+1K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+1K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+1K110694Concorde Bullet Spinal SystemJohnson & Johnson2011227—
+1K111835Plateau Spacer SystemLife Spine, Inc.2011120—
+1K110843Aleutian Spacer SystemK2m, Inc.2011589—
+1K110927MectalifMedacta International2011301
+1K110454Cougar LS Lateral Cage SystemJohnson & Johnson2011602—
+1K102606Avs Anchor-C Cervical Cage SystemStryker Spine20113841
+1K103169AleuttianK2m, Inc.2011572—
+1K103488Concorde Bullet Cage SystemJohnson and Johnson201129—
+1K101923Concorde Curve SystemDepuy Spine2010609—
+1K093093Small Plateau Spacer SystemLife Spine2010393—
+1K101812Construx Mini Peek Spacer SystemOrthofix, Inc.2010291—
+1K101302Aleutian Ibf SystemK2m, Inc.2010595—
+2K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K242303MOD-COrthomod, LLC20260—
+2K251016MectaLIF 3D MetalMedacta International S.A.20250—
+2K241073DZ-Tabone Intervertebral Body Fusion DeviceShenzhen Dazhou Medical Technology Co., Ltd.20240—
+2K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+2K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+2K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+2K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+2K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+2K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+2K212831MectaLIF ExtensionMedacta International S.A.20211—
+2K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+2K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+2K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+2K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+2K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+2K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+2K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+2K192906Mecta-C Stand AloneMedacta International S.A.20201—
+2K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+2K190284Bengal Stackable Cage SystemMedos International SARL20190—
+2K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+2K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+2K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+2K183092Kuros TLIF CageKuros Biosciences B.V20190—
+2K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+2K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+2K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+2K181899Roccia® PlifSilony Medical GmbH20180—
+2K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+2K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+2K181397DualXInnovasive, Inc.201815—
+2K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+2K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+2K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+2K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+2K172480icotec Interbody Cage SystemIcotec AG20185—
+2K172568CervagePrecifit Medical, Ltd.20181—
+2K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+2K173128Alamo® CAlliance Partners, LLC20182—
+2K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+2K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+2K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+2K172020Arlington PLIF/TLIF CageSignature Orthopaedics Pty, Ltd.20170—
+2K170235Lucent®Spinal Elements, Inc.2017107—
+2K172424Velofix™ SA Cervical CageU&I Corporation201751
+2K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+2K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+2K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+2K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+2K163180Hubble IIOrbbo Surgical, LLC20160—
+2K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+2K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+2K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+2K160125Cascadia Interbody SystemK2m2016315—
+2K160547Cascadia Interbody SystemK2m2016157—
+2K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+2K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+2K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+2K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+2K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+2K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+2K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+2K150481Cascadia Interbody SystemK2m, Inc.20154593