510(k) Report

Devices descending from K011406

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+5K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+5K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+5K120928Synthes Matrix SystemSynthes Spine20120—
+5K121020Viper SystemDepuy Spine, Inc.201294—
+5K120517Depuy Pulse Cervical Cage SystemMedos International SARL20123—
+5K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+5K120656Everest Spinal SystemK2m, Inc.201243—
+5K120696Tiger Spine SystemCorelink, LLC201241—
+5K120576Zavation Ibf SystemZavation, LLC201232—
+5K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+5K113478Plif CageEisertech, LLC2012269—
+5K113518Arena-C Cervical Intervertebral Body Fusion SystemSpinefrontier, Inc.2012193—
+5K113138Aleutian SystemK2m, Inc.2012549—
+5K113559LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc.2011383—
+5K112664Zavation Ibf SystemsZavation, LLC201137—
+5K112862Mecta-CMedacta International201114—
+5K111123Varilift Cervical Interbody Fusion SystemWenzel Spine2011196—
+5K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+5K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+5K111512Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc.2011762—
+5K110783Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd.201138—
+5K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc.2011268—
+5K111484DiscoveryIntuitive Spine, LLC20111—
+5K102315Staxx XDL SystemSpine Wave, Inc.20113—
+5K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+5K110915Cervical CageEisertech, LLC201123—
+5K111469Staxxsd SystemSpine Wave, Inc.20110—
+5K110864Biospine VBR SystemAesculap Implant Systems, LLC201149—
+5K102606Avs Anchor-C Cervical Cage SystemStryker Spine20113841
+5K110177Helena SystemRoyal Oak Medical Devices20110—
+5K102402Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc.20111121
+5K101971Syntec OS Spinal Fixation SystemSyntec Scientific Corp.20110—
+5K100698STCCCardinal Spine, LLC2011346—
+5K103660Lanx Cervical Intervertebral Body Fusion SystemLanx, Inc.201141—
+5K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+5K101812Construx Mini Peek Spacer SystemOrthofix, Inc.2010291—
+5K100889Endoskeleton TCTitan Spine, LLC2010455—
+5K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+5K092325Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20093—
+5K091946Vlift-S Vertebral Body Replacement System, Models 488812XX, 488814XX, 488816XX, 488818XXStryker Spine20095—
+5K090315Staxx XD SystemSpine Wave, Inc.20096—
+5K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+5K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+5K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531
+5K080860Creaspine Supstance Small Vertebral Body Replacement SystemCreaspine20080—
+5K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc.2008637—
+5K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+5K070218Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated200760—
+5K062606CD Horizon Spinal SystemMedtronic Sofamor Danek20062—
+5K061836Avs Asl Peek Spacer SystemStryker Spine2006213—
+5K060350Construx PL/TL Peek Partial VBR SystemBlackstone Medical, Inc.2006754—
+6K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+6K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+6K261049Scala® TLSpineart SA20260—
+6K261408SABER-XA SystemElevation Spine20260—
+6K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+6K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K253260ORIO-3D Cage SystemSpineCraft20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+6K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+6K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+6K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+6K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+6K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+6K252742Navigated InstrumentsTyber Medical, LLC20251—
+6K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+6K252322SIros-X SystemGenesys Spine20250—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+6K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+6K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+6K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+6K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+6K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+6K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+6K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+6K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+6K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—