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
+2K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+2K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+2K1421124WEB Spinal Implant Products4Web, Inc.201433—
+2K141337Arena-CSpinefrontier, Inc.20141—
+2K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+2K141005Z-Link CervicalZavation, LLC20144—
+2K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+2K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+2K133784Vista-S Device, Associated InstrumentationZimmer Trabecular Metal Technology201429—
+2K140759Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar…Medos International SARL2014204—
+2K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+2K133200Stalif C (R)Centinel Spine, Inc.201410—
+2K140066Infill CervicalPinnacle Spine Group, LLC20140—
+2K133653Anatomic Peek PTC Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.2014286—
+2K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+2K132596Proposed OptimusCustom Spine, Inc.201451
+2K140003Coroent Small Interbody SystemNuvasive, Inc.2014453—
+2K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+2K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+2K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+2K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+2K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+2K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+2K133192Mectalif TipeekMedacta International201416—
+2K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+2K133321Alamo CAlliance Partners, LLC20143—
+2K131880Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device SystemSpinefrontier, Inc.201427—
+2K130913Genesys Spine Apache Lateral Lumbar Interbody Fusion SystemGenesys Spine201314—
+2K133126K7 Lumbar SpacersK7, LLC20131—
+2K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+2K130853Idys (TM) CClariance20132—
+2K130274Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemElite Surgical Supplies (Pty), Ltd.20139—
+2K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+2K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+2K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+2K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+2K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+2K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.201312—
+2K131671MectalifMedacta International201322—
+2K121178Transcorp Acif SystemTranscorp, Inc.20130—
+2K131372Mobis IISignus Medizintechnik GmbH2013462—
+2K122588Vusion CS PlusOrtho Development Corp.2013206—
+2K122639Synthes Syncage Evolution SpacerSynthes (USA) Products, LLC2013143—
+2K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+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—
+2K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+2K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+2K122008Incite Anchored Cervical Interbody (Aci) Fusion DeviceIncite Innovation, LLC201210—
+2K120401Alamo TAlliance Partners, LLC20121—
+2K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+2K120819Stalif CCentinel Spine, Inc.2012206—
+2K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Ldr Spine USA, Inc.201216—
+2K121176STGCCardinal Spine, LLC201259—
+2K121320C7 Anterior Cervical Intervertebral Fusion CageMedyssey Co, Ltd.20122—
+2K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+2K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp201230—
+2K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+2K113561TM Ardis Interbody System TM Ardis Interbody System InstrumenationZimmer Trabecular Metal Technology20124762
+2K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+2K110632Lucent or Lucent MagnumSpinal Elements, Inc.20126941
+2K112801Ayers Rock Cervical CageQualgenix20122—
+2K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+2K120517Depuy Pulse Cervical Cage SystemMedos International SARL20123—
+2K112696Twin Peaks Lumbar CageQualgenix, LLC20120—
+2K120576Zavation Ibf SystemZavation, LLC201232—
+2K120024Mectalif TransforaminalMedacta International S.A.201223—
+2K113518Arena-C Cervical Intervertebral Body Fusion SystemSpinefrontier, Inc.2012193—
+2K120143Eclipse Vertebral Spacer System-CervicalApollo Spine20120—
+2K113559LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc.2011383—
+2K112664Zavation Ibf SystemsZavation, LLC201137—
+2K113348Cougar SystemJohnson & Johnson2011591—
+2K112459Synthes Zero-PSynthes Spine Co.Lp2011277—
+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—
+2K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+2K110694Concorde Bullet Spinal SystemJohnson & Johnson2011227—
+2K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+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—
+2K111835Plateau Spacer SystemLife Spine, Inc.2011120—
+2K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+2K110843Aleutian Spacer SystemK2m, Inc.2011589—
+2K110927MectalifMedacta International2011301
+2K110454Cougar LS Lateral Cage SystemJohnson & Johnson2011602—
+2K110177Helena SystemRoyal Oak Medical Devices20110—
+2K110067LP CageMedyssey Co, Ltd.201115—
+2K110585Captiva Spine Fuselox Cervical CageCaptiva Spine, Inc.20111—
+2K103111Forza Spacer SystemOrthofix, Inc.20113431
+2K100698STCCCardinal Spine, LLC2011346—
+2K103169AleuttianK2m, Inc.2011572—
+2K103488Concorde Bullet Cage SystemJohnson and Johnson201129—
+2K103660Lanx Cervical Intervertebral Body Fusion SystemLanx, Inc.201141—
+2K100945Fuse Plif CafeAdvanced Medical Technologies AG2011463—