510(k) Report

Devices descending from K020522

1,234 later devices reach Modification to Surgical Titanium Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+6K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+6K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+6K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+6K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+6K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+6K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+6K152622Alta ACDF SystemBiomet Spine20160—
+6K152011Lucent Intervertebral Body Fusion DeviceSpinal Elements, Inc.2016106—
+6K153436LATERAL Spine Truss System4Web, Inc.20165—
+6K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+6K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+6K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+6K152539SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.20166—
+6K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+6K151481Sahara Stabilization SystemK2m, Inc.20155—
+6K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+6K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+6K152304Tritanium PL CageStryker20154481
+6K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+6K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+6K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+6K151756Sterispine LC CageSafe Orthopaedics20150—
+6K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+6K151483Biomet Spine Fusion SystemBiomet Spine, LLC20154—
+6K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+6K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+6K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+6K142392Zavation Posterior LEIFZavation, LLC20150—
+6K143616AccuLIF TL and PL CageStryker Corporation20154694
+6K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+6K142271Zavation Z-Link LumbarZavation, LLC20149—
+6K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+6K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+6K141005Z-Link CervicalZavation, LLC20144—
+6K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+6K133893Sterispine LC CageSafe Orthopaedics20141—
+6K133583Opticage Interbody Fusion Device, Model Series 9070Interventional Spine, Inc.20140—
+6K132559Monument SpacersGlobus Medical, Inc.2013166—
+6K131071Staxx Ibl SystemSpine Wave, Inc.20138—
+6K130194Acculif XL CageCoalign Innovations, Inc.20131—
+6K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+6K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+6K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+7K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+7K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+7K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+7K2530413d Cage CervicalFims Co., Ltd.20260—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K261279DeltaNEC Interbody SystemNexus Spine20260—
+7K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+7K261067BEE PLIF CageNGMedical GmbH20260—
+7K260660SABER-C SystemElevation Spine20261—
+7K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+7K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K253545Vulcan Spinal SystemK2m, Inc.20260—
+7K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+7K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+7K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+7K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+7K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+7K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+7K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+7K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+7K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+7K250540SABER-C SystemElevation Spine20252—
+7K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+7K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+7K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K243474MagnetOs MISKuros Biosciences B.V20250—
+7K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+7K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+7K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+7K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+7K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+7K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+7K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K242589Scarlet® AL-TSpineart SA20240—
+7K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+7K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—