510(k) Report

Devices descending from K841189

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K123388K7C SpacerK7, LLC20130—
+4K120869Anchor-L Lumbar CageStryker Spine2012638—
+4K121581Box Peek VBR System,Innovasis, Inc.20121—
+4K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+4K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+4K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Ldr Spine USA, Inc.201216—
+4K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+4K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+4K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+4K121107Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc.2012214—
+4K112986Lateral Fusion DeviceIntegra Spine (Integra Lifesciences)2012126—
+4K120517Depuy Pulse Cervical Cage SystemMedos International SARL20123—
+4K112696Twin Peaks Lumbar CageQualgenix, LLC20120—
+4K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+4K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+4K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+4K113478Plif CageEisertech, LLC2012269—
+4K120024Mectalif TransforaminalMedacta International S.A.201223—
+4K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+4K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012292—
+4K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+4K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+4K112862Mecta-CMedacta International201114—
+4K111119Trabecular Metal (TM) Fusion DeviceZimmer Spine, Inc.201152—
+4K112493Pass LP Spinal SystemMedicrea International20111—
+4K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+4K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+4K111965Vusion (R) OSOrtho Development20110—
+4K110783Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd.201138—
+4K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011597—
+4K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+4K110153SFC Vertebral Body ReplacementKonigsee Implantate GmbH20110—
+4K110694Concorde Bullet Spinal SystemJohnson & Johnson2011227—
+4K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+4K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+4K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+4K110659Medical Concepts Interbody Fusion SystemMedical Concepts, Inc.20111—
+4K111626Endoskeleton (R) TasTitan Spine, LLC2011273—
+4K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011355—
+4K102315Staxx XDL SystemSpine Wave, Inc.20113—
+4K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+4K110915Cervical CageEisertech, LLC201123—
+4K111835Plateau Spacer SystemLife Spine, Inc.2011120—
+4K111571Viper SystemsJohnson & Johnson2011203—
+4K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+4K110843Aleutian Spacer SystemK2m, Inc.2011589—
+4K110864Biospine VBR SystemAesculap Implant Systems, LLC201149—
+4K110927MectalifMedacta International2011301
+4K110454Cougar LS Lateral Cage SystemJohnson & Johnson2011602—
+4K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+4K102606Avs Anchor-C Cervical Cage SystemStryker Spine20113841
+4K103369Vault Alif SystemSpinal USA201110—
+4K103169AleuttianK2m, Inc.2011572—
+4K103488Concorde Bullet Cage SystemJohnson and Johnson201129—
+4K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+4K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+4K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+4K101923Concorde Curve SystemDepuy Spine2010609—
+4K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517—
+4K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010598—
+4K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+4K093093Small Plateau Spacer SystemLife Spine2010393—
+4K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies2010864—
+4K101812Construx Mini Peek Spacer SystemOrthofix, Inc.2010291—
+4K101301Stalif MidlineCentinel Spine2010474—
+4K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+4K100889Endoskeleton TCTitan Spine, LLC2010455—
+4K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+4K101302Aleutian Ibf SystemK2m, Inc.2010595—
+4K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+4K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+4K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029—
+4K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+4K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+4K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+4K093242Patriot Transcontinental Llif SpacerGlobus Medical, Inc.2009921—
+4K092904Pathway Ivb/VBRCustom Spine, Inc.2009296—
+4K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+4K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009776—
+4K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009901—
+4K083815Lanx Fusion SystemLanx, Inc.2009451—
+4K083714Endoskeleton TT Interbody Fusion Device (Ibd)Titan Spine, LLC2009412—
+4K090064Eminent Spine Interbody Fusion SystemEminent Spine20097011
+4K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+4K083825Eoi Spinal SystemExpanding Orthopedics, Inc.20090—
+4K083475Lucent MagnumSpinal Elements, Inc.2009834—
+4K083857LDR Spine Roi-C ImplantLdr Spine USA2009902—
+4K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+4K082466Xycor Spinal ImplantVertebration,Inc200942—
+4K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+4K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek2008716—
+4K081711Lucent Magnum+Spinal Elements, Inc.20080—
+4K080971Spinesmith Cimplicity Spinal SystemSpine Smith Partners L.P.2008406—
+4K080728LDR Spine Roi-C ImplantLdr Spine USA2008903—
+4K080569LDR Spine Roi-T ImplantLdr Spine USA20080—
+4K080572LDR Spine Roi-a ImplantLdr Spine USA2008113—
+4K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+4K071726ZUMASeaspine, Inc.200712—
+4K072132LDR Spine Roi-T SystemLdr Spine USA20071—
+4K071033T2 XVBR Spinal SystemMedtronic Sofamor Danek200750—