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
+6K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+6K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+6K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+6K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+6K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+6K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+6K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722—
+6K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+6K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+6K172065Scarlet AC-TSpineart20172—
+6K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+6K171519FLXfit™Expanding Orthopedics, Inc.2017711
+6K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+6K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+6K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+6K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+6K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+6K160715AccuLIF TL and PL CageStryker Corporation20160—
+6K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+6K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+6K141217Acculif TL and PL CageStryker Corporation20146423
+6K133784Vista-S Device, Associated InstrumentationZimmer Trabecular Metal Technology201429—
+6K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+6K130853Idys (TM) CClariance20132—
+6K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+6K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+6K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+6K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+6K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+7K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+7K263049SABER-C SystemElevation Spine20260—
+7K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+7K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+7K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+7K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+7K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+7K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+7K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+7K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+7K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+7K243474MagnetOs MISKuros Biosciences B.V20250—
+7K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+7K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+7K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+7K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+7K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+7K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+7K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+7K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+7K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+7K234150Lucent® XPSpinal Elements20240—
+7K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+7K240453ReBOSSISOrthorebirth Co., Ltd.202402
+7K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+7K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+7K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+7K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+7K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+7K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+7K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+7K230989Rod Registration FrameNu Vasive, Incorporated20230—
+7K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+7K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+7K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+7K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+7K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+7K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+7K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+7K211306LabyrinthZavation Medical Products, LLC20213—
+7K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—