510(k) Report

Devices descending from K011406

2,048 later devices reach Spinal Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K131250Tiger Spine SystemCorelink, LLC201340—
+6K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+6K131784Range Spinal SystemK2m, Inc.201334—
+6K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+6K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+6K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+6K131343Reform Pedicle Screw SystemSpinal USA201331—
+6K130279Reform Pedicle Screw SystemSpinal USA201331—
+6K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+6K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+6K131030Range Spinal SystemK2m, Inc.201334—
+6K130330Range Spinal SystemK2m, Inc.201336—
+6K130306Incite Anchored Cervical Interbody DeviceIncite Innovation, LLC20131—
+6K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+6K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+6K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+6K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+6K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+6K123134Easyspine SystemLdr Spine USA, Inc.20131—
+6K120603Varilift -CWenzel Spine2013193—
+6K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+6K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+6K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+6K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+6K123246CD Horizon Spire Z Spinal SystemMedtronic Sofamor Danek20122—
+6K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+6K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+6K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+6K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+6K122021Sterispine LC CageSafe Orthopaedics20122—
+6K120819Stalif CCentinel Spine, Inc.2012206—
+6K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+6K121107Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc.2012214—
+6K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+6K112459Synthes Zero-PSynthes Spine Co.Lp2011277—
+6K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+6K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+6K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+6K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+6K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+6K102323Cervical Standalone Intervertebral Body Fusion DeviceTheken Spine, LLC201062—
+6K101288Staxx XD SystemSpine Wave, Inc.201051
+6K094042Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2010397—
+6K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+6K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+6K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+6K082270Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc.200855—
+6K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+7K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K261430TruLift Expandable SystemLife Spine, Inc.20260—
+7K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+7K2530413d Cage CervicalFims Co., Ltd.20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+7K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+7K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+7K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+7K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+7K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+7K261067BEE PLIF CageNGMedical GmbH20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K252774Uni-C Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+7K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K253545Vulcan Spinal SystemK2m, Inc.20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+7K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+7K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+7K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+7K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+7K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+7K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+7K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+7K250769Dakota LP SystemPrecision Spine, Inc.20250—
+7K250560BEE HANGMedical GmbH20250—
+7K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—