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
+5K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+5K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+5K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+5K111569Plateau Spacer SystemLife Spine2011181—
+5K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+5K103382Intercontinental Plate-SpacerGlobus Medical, Inc.2011554—
+5K103729Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC201122—
+5K103111Forza Spacer SystemOrthofix, Inc.20113431
+5K103743Concorde Curve SystemJohnson & Johnson20110—
+5K100945Fuse Plif CafeAdvanced Medical Technologies AG2011463—
+5K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+5K102293Caliber SpacerGlobus Medical, Inc.2011869—
+5K102313Patriot Transcontinental M SpacersGlobus Medical, Inc.2010361—
+5K101288Staxx XD SystemSpine Wave, Inc.201051
+5K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+5K101051Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXStryker Spine2010641—
+5K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+5K100175Clydesdale Spinal SystemMedtronic Sofamor Danek20101,008—
+5K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—
+5K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+5K091813Intrepid Spinal SystemMedtronic Sofamor Danek2009719—
+5K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009796—
+5K082801Phantom Plus Cage SystemUs Spine2008643—
+5K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+5K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek2008716—
+5K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008907—
+5K052210Nuvasive Coroent Extensure SystemNuvasive, Inc.2005263—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K261430TruLift Expandable SystemLife Spine, Inc.20260—
+6K2530413d Cage CervicalFims Co., Ltd.20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+6K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+6K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+6K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+6K261067BEE PLIF CageNGMedical GmbH20260—
+6K260660SABER-C SystemElevation Spine20261—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+6K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+6K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+6K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+6K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+6K250540SABER-C SystemElevation Spine20252—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+6K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+6K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc.20251—
+6K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+6K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+6K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+6K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+6K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+6K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+6K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+6K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+6K242589Scarlet® AL-TSpineart SA20240—
+6K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+6K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+6K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+6K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+6K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+6K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+6K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+6K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+6K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+6K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+6K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+6K240368E3D™-A Interbody SystemEvolution Spine20247—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—