510(k) Report

Devices descending from P000028

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K133200Stalif C (R)Centinel Spine, Inc.201410—
+2K133815Intess Cervical Cage SystemKalitec Direct, LLC20144—
+2K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+2K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+2K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+2K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+2K131880Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device SystemSpinefrontier, Inc.201427—
+2K130913Genesys Spine Apache Lateral Lumbar Interbody Fusion SystemGenesys Spine201314—
+2K130317Genesys Spine Apache Ibfd Star Cervical SystemGenesys Spine20139—
+2K133126K7 Lumbar SpacersK7, LLC20131—
+2K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+2K132718Integrity Spine Core SystemIntegrity Spine20131—
+2K130853Idys (TM) CClariance20132—
+2K130274Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemElite Surgical Supplies (Pty), Ltd.20139—
+2K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+2K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.201312—
+2K121178Transcorp Acif SystemTranscorp, Inc.20130—
+2K131372Mobis IISignus Medizintechnik GmbH2013462—
+2K122588Vusion CS PlusOrtho Development Corp.2013206—
+2K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+2K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+2K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+2K123969XiphosDifusion Technologies201314—
+2K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454—
+2K123388K7C SpacerK7, LLC20130—
+2K122008Incite Anchored Cervical Interbody (Aci) Fusion DeviceIncite Innovation, LLC201210—
+2K120401Alamo TAlliance Partners, LLC20121—
+2K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+2K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Ldr Spine USA, Inc.201216—
+2K121176STGCCardinal Spine, LLC201259—
+2K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+2K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+2K113561TM Ardis Interbody System TM Ardis Interbody System InstrumenationZimmer Trabecular Metal Technology20124762
+2K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+2K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+2K112801Ayers Rock Cervical CageQualgenix20122—
+2K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+2K120517Depuy Pulse Cervical Cage SystemMedos International SARL20123—
+2K120576Zavation Ibf SystemZavation, LLC201232—
+2K120024Mectalif TransforaminalMedacta International S.A.201223—
+2K113518Arena-C Cervical Intervertebral Body Fusion SystemSpinefrontier, Inc.2012193—
+2K113559LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc.2011383—
+2K112664Zavation Ibf SystemsZavation, LLC201137—
+2K112459Synthes Zero-PSynthes Spine Co.Lp2011277—
+2K111123Varilift Cervical Interbody Fusion SystemWenzel Spine2011196—
+2K111119Trabecular Metal (TM) Fusion DeviceZimmer Spine, Inc.201152—
+2K111983Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology201131—
+2K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+2K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+2K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+2K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+2K110659Medical Concepts Interbody Fusion SystemMedical Concepts, Inc.20111—
+2K111484DiscoveryIntuitive Spine, LLC20111—
+2K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+2K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+2K110177Helena SystemRoyal Oak Medical Devices20110—
+2K100698STCCCardinal Spine, LLC2011346—
+2K103660Lanx Cervical Intervertebral Body Fusion SystemLanx, Inc.201141—
+2K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+2K093762Synthes Zero-PSynthes Spine20103061
+2K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+2K092521ZUMA-CSeaspine, Inc.2010168—
+2K081917Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc.20091,008—
+2K080971Spinesmith Cimplicity Spinal SystemSpine Smith Partners L.P.2008406—
+2K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008907—
+3K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+3K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+3K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+3K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+3K253260ORIO-3D Cage SystemSpineCraft20260—
+3K242303MOD-COrthomod, LLC20260—
+3K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+3K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+3K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+3K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+3K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+3K241073DZ-Tabone Intervertebral Body Fusion DeviceShenzhen Dazhou Medical Technology Co., Ltd.20240—
+3K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+3K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+3K240368E3D™-A Interbody SystemEvolution Spine20247—
+3K240699SCARLET® AC-TiSpineart SA20240—
+3K240715Idys® C ZP 3DTiClariance20240—
+3K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+3K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+3K232432E3D™-A Interbody SystemEvolution Spine20248—
+3K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+3K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+3K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—