510(k) Report

Devices descending from P000028

1,287 later devices reach Affinity (TM) Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173148ACIFColigne AG20171—
+1K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+1K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+1K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+1K120819Stalif CCentinel Spine, Inc.2012206—
+1K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+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—
+1K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+1K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+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—
+1K090064Eminent Spine Interbody Fusion SystemEminent Spine20097011
+1K072981Synthes Zero-PSynthes Spine Co.Lp20085462
+1K073320Cimplicity Spinal SystemSpine Smith Partners L.P.20081,018—
+1K072415Stalif (TM) CSurgicraft, Ltd.2008948—
+2K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+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—
+2K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+2K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+2K230219Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC20234—
+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—
+2K212358Romero Cervical CageSpineup, Inc.20226—
+2K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+2K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+2K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+2K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+2K200312Tryptik TiSpineart20202—
+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—
+2K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+2K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+2K1803473d CageFims Co., Ltd.20190—
+2K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+2K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+2K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC20190—
+2K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+2K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+2K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+2K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+2K182477Cervical SpacerAdditive Implants, LLC201915—
+2K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+2K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+2K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC201801
+2K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+2K173453Valeo® C+CSC with Lumen Interbody Fusion DeviceAmedica Corp.20180—
+2K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+2K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+2K172330Blustone Synergy Silica SystemBlustone Synergy20170—
+2K172424Velofix™ SA Cervical CageU&I Corporation201751
+2K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+2K172065Scarlet AC-TSpineart20172—
+2K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+2K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+2K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+2K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+2K163494Summit Spine Channel Cervical Interbody Fusion SystemSummit Spine20171—
+2K162206Zavation IBFZavation, LLC201724—
+2K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+2K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+2K162531Sterispine CCSafe Orthopaedics20160—
+2K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)Evolution Spine, LLC20160—
+2K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+2K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+2K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+2K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+2K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.201612—
+2K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+2K160324Cervical Interbody Fusion SystemEvolution Spine, LLC20162—
+2K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+2K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+2K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+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—
+2K150812Genesys Spine Apache Cervical Interbody Fusion SystemGenesys Spine201512—
+2K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+2K150847Foundation Interbody DevicesCorelink, LLC201529—
+2K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+2K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+2K141798Sypher Spacer SystemBiogennix, LLC20151—
+2K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+2K142328nvcNvision Biomedical Technologies, LLC20144—
+2K142041Porosteon Phusion Metal Cervical CagePorosteon, Inc.20141—
+2K142594nva, nvp, nvtNvision Biomedical Technologies, LLC20144—
+2K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+2K142026Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.2014190—
+2K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+2K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+2K141337Arena-CSpinefrontier, Inc.20141—
+2K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+2K141005Z-Link CervicalZavation, LLC20144—
+2K133784Vista-S Device, Associated InstrumentationZimmer Trabecular Metal Technology201429—
+2K133494Chesapeake Spinal SystemK2m, Inc.2014330—