510(k) Report

Devices descending from P950019

1,482 later devices reach Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+5K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+5K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+5K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+5K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+5K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+5K162496Foundation 3D InterbodyCorelink, LLC201782—
+5K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+5K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017289—
+5K162921Navigated Instrument SystemOrthofix, Inc.20175—
+5K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+5K162587Roccia® AcifSilony Medical GmbH20171—
+5K162262Tritanium® PL CageStryker2016132—
+5K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+5K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+5K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+5K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+5K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+5K160955Tritanium® PL CageStryker2016178—
+5K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+5K152622Alta ACDF SystemBiomet Spine20160—
+5K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+5K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+5K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+5K153400ProLift Expandable SystemLife Spine, Inc.201672—
+5K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+5K152651AccuLIF TL and PL CageStryker Corporation201530—
+5K143479Bluefin Interbody SystemTides Medical20152—
+5K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+5K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+5K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+5K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+5K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+5K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+5K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+5K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+5K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+5K130194Acculif XL CageCoalign Innovations, Inc.20131—
+5K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+5K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+5K121320C7 Anterior Cervical Intervertebral Fusion CageMedyssey Co, Ltd.20122—
+5K111983Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology201131—
+5K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+6K261430TruLift Expandable SystemLife Spine, Inc.20260—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+6K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+6K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+6K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+6K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+6K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+6K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+6K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+6K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+6K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+6K250556Porous Biologic ScaffoldVentris Medical20250—
+6K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+6K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+6K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+6K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+6K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+6K241895Cannulated PsiFGuardSpineguard20240—
+6K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+6K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+6K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+6K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+6K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+6K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+6K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+6K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+6K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+6K240442MagnetOs PuttyKuros Biosciences B.V20243—
+6K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+6K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+6K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K240458Synthetic Bone PuttyVentris Medical20242—
+6K240459Cerament Bone Void FillerBonesupport AB20240—
+6K232347MagnetOs GranulesKuros Biosciences B.V20242—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—