510(k) Report

Devices descending from K841189

2,425 later devices reach Oec/Rezaian Spinal Fixator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+4K170271NuVasive (r) Monolith Corpectomy SystemNu Vasive, Incorporated201712—
+4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+4K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+4K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+4K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+4K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+4K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+4K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K153665Prow Fusion-LNlt Spine, Ltd.20160—
+4K161129Pillar SA PTCOrthofix, Inc.201619—
+4K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+4K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+4K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+4K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+4K160291Optimus ALIF SystemAmendia, Inc.20160—
+4K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+4K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+4K152460Rectangular Corpectomy CageAmendia, Inc.20150—
+4K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+4K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+4K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+4K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+4K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+4K151651NuVasive X-CORE Mini Cervical Expandable VBR SystemNu Vasive, Incorporated201568—
+4K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+4K151538NuVasive PEEK Corpectomy Railed SystemNu Vasive, Incorporated201513—
+4K151167NuVasive PEEK Corpectomy SystemNu Vasive, Incorporated201513—
+4K150847Foundation Interbody DevicesCorelink, LLC201529—
+4K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+4K143143Pathway ElifCustom Spine, Inc.201514—
+4K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+4K142005SpineFab Vertebral Body Replacement (VBR) SystemOxford Performance Materials201513—
+4K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+4K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+4K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+4K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+4K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+4K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+4K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+4K141187Impix Alif S/aMedicrea International SA201501
+4K142488SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…Seaspine, Inc.2014116—
+4K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2014212—
+4K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+4K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+4K140319Coroent TI-C SystemNuvasive, Inc.2014590—
+4K140577Innesis Peek TL CageBk Meditech, Co., Ltd.20142—
+4K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+4K141494CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014273—
+4K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+4K132907Plif Lite and Tlif LiteSintea Plustek20140—
+4K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+4K132852Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A20140—
+4K140066Infill CervicalPinnacle Spine Group, LLC20140—
+4K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+4K133802Ais Modulift VBR SystemAesculap Implant System, Inc.201448—
+4K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+4K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+4K133893Sterispine LC CageSafe Orthopaedics20141—
+4K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+4K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+4K132421Aesculap Peek XP Spinal Implant SystemAesculap Implant Systems, Inc.201414—
+4K123758Tasmin RSignus Medizintechnik GmbH20141—
+4K133286Midline (TM)Centinel Spine, Inc.2014460—
+4K133321Alamo CAlliance Partners, LLC20143—
+4K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+4K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+4K133126K7 Lumbar SpacersK7, LLC20131—
+4K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+4K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+4K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+4K132718Integrity Spine Core SystemIntegrity Spine20131—
+4K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+4K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+4K130254Prow FusionNlt Spine, Ltd.20138—
+4K131636Polarus ConnectAcumed, LLC20130—
+4K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+4K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+4K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+4K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+4K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+4K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+4K130461Stalif XCentinel Spine, Inc.201313—
+4K130820Expandable Lumbar Interbody SystemNu Vasive, Incorporated2013593—
+4K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+4K131671MectalifMedacta International201322—
+4K122588Vusion CS PlusOrtho Development Corp.2013206—
+4K122639Synthes Syncage Evolution SpacerSynthes (USA) Products, LLC2013143—
+4K124034Mectalif AnteriorMedacta International201311—
+4K123913Latis SpacerGlobus Medical, Inc.201388—
+4K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+4K123909Aesculap Cespace XPAesculap Implant System, Inc.20137—
+4K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+4K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+4K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454—
+4K123969XiphosDifusion Technologies201314—