510(k) Report

Devices descending from P980048

1,422 later devices reach Bak/Cervical (Bak/C) Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253260ORIO-3D Cage SystemSpineCraft20260—
+1K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+1K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+1K182477Cervical SpacerAdditive Implants, LLC201915—
+1K181471ACCUFUSE Cervical SystemAbsolute Advantage Medical, LLC20180—
+1K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+1K173148ACIFColigne AG20171—
+1K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+1K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+1K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+1K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+1K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+1K133815Intess Cervical Cage SystemKalitec Direct, LLC20144—
+1K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+1K130317Genesys Spine Apache Ibfd Star Cervical SystemGenesys Spine20139—
+1K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+1K132718Integrity Spine Core SystemIntegrity Spine20131—
+1K130478Sustain and Sustain Radiolucent SpacersGlobus Medical, Inc.2013256—
+1K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+1K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454—
+1K120603Varilift -CWenzel Spine2013193—
+1K123388K7C SpacerK7, LLC20130—
+1K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+1K122085Stingray Cervical CageOmni Surgical, LP Dba Spine36020120—
+1K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+1K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+1K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+1K112862Mecta-CMedacta International201114—
+1K111123Varilift Cervical Interbody Fusion SystemWenzel Spine2011196—
+1K112036Calix PC Spinal Implant SystemX-Spine Systems, Inc.2011775—
+1K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+1K110733Daytona Anterior Cervical CageSpinenet, LLC20114811
+1K103655Octane-C Interbody Fusion Device SystemExactech, Inc.2011481
+1K102606Avs Anchor-C Cervical Cage SystemStryker Spine20113841
+1K103033Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and 08-100-XxxxxZimmer Trabecular Metal Technology2011505—
+1K102322Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant…Omni Surgical, L.P.20116—
+1K101588Eclipse Vertebral Spacer System-CervicalApollo Spine, Inc.20111—
+1K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+1K092794Transcorp Acif SystemTranscorp, Inc.20104—
+1K100889Endoskeleton TCTitan Spine, LLC2010455—
+1K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+1K092904Pathway Ivb/VBRCustom Spine, Inc.2009296—
+1K091873Tryptik CA Anterior Intersomatic Cervical Cage, Models Mos-CA 12 05-S, Mos-CA 12 O6-SSpineart2009106—
+1K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009901—
+1K081917Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc.20091,008—
+1K090064Eminent Spine Interbody Fusion SystemEminent Spine20097011
+1K083167Phenix Cervical Interbody DeviceSpinal Devices, LLC200914—
+1K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc.2008637—
+1K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20087751
+1K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG2008840—
+1K073440Foundation CageCorelink, LLC2008126—
+1K072981Synthes Zero-PSynthes Spine Co.Lp20085462
+1K072415Stalif (TM) CSurgicraft, Ltd.2008948—
+1K072226Impix SpacerMedicrea Technologies2007812—
+2K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+2K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+2K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+2K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+2K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+2K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+2K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+2K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+2K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+2K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+2K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+2K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+2K230219Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC20234—
+2K223043The Integrity Spine Core SystemIntegrity Spine20230—
+2K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+2K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+2K212701Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine20235—
+2K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+2K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+2K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+2K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+2K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+2K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+2K201287Impulse Interbody Fusion SystemDegen Medical20208—
+2K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+2K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+2K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+2K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+2K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+2K200312Tryptik TiSpineart20202—
+2K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+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—
+2K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+2K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+2K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+2K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+2K1803473d CageFims Co., Ltd.20190—
+2K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+2K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+2K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+2K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+2K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC20190—
+2K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+2K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—