510(k) Report

Devices descending from K003709

1,714 later devices reach Surgical Dynamics Mesh Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K182584Lucent® XPSpinal Elements, Inc.20183—
+5K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+5K182470Plateau Spacer SystemLife Spine20180—
+5K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+5K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+5K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+5K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+5K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+5K181818Scarlet AL-TSpineart201864—
+5K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+5K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+5K181397DualXInnovasive, Inc.201815—
+5K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+5K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+5K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+5K181337Sypher Spacer SystemBiogennix, LLC20180—
+5K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+5K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+5K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+5K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+5K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+5K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+5K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+5K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+5K181203Juliet TiSpineart20181—
+5K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+5K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+5K172480icotec Interbody Cage SystemIcotec AG20185—
+5K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+5K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+5K180687Reliance Lumber IBF SystemReliance Medical Systems20188—
+5K172568CervagePrecifit Medical, Ltd.20181—
+5K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+5K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+5K173128Alamo® CAlliance Partners, LLC20182—
+5K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+5K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+5K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+5K173702Juliet Ti LLSpineart20182—
+5K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+5K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+5K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+5K172009Cascadia Interbody SystemK2m, Inc.2017433
+5K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+5K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+5K172020Arlington PLIF/TLIF CageSignature Orthopaedics Pty, Ltd.20170—
+5K172424Velofix™ SA Cervical CageU&I Corporation201751
+5K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+5K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.201746—
+5K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+5K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+5K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+5K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+5K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+5K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+5K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+5K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+5K171519FLXfit™Expanding Orthopedics, Inc.2017711
+5K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+5K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+5K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+5K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+5K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+5K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+5K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+5K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+5K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+5K162206Zavation IBFZavation, LLC201724—
+5K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+5K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+5K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+5K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+5K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+5K163180Hubble IIOrbbo Surgical, LLC20160—
+5K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+5K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+5K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+5K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+5K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+5K161379ELSA SpacersGlobus Medical, Inc.2016155—
+5K153665Prow Fusion-LNlt Spine, Ltd.20160—
+5K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+5K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+5K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+5K153786Prow Fusion-VNlt Spine, Ltd.20166—
+5K152622Alta ACDF SystemBiomet Spine20160—
+5K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+5K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+5K160995NEOVIEW Plating SystemIn2bones Sas201624
+5K153436LATERAL Spine Truss System4Web, Inc.20165—
+5K160463Reliance Lumbar IBF SystemReliance Medical Systems, LLC201611—
+5K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+5K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+5K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+5K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+5K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+5K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+5K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+5K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+5K160291Optimus ALIF SystemAmendia, Inc.20160—