510(k) Report

Devices descending from K111264

331 later devices reach Cornerstone (R) PSR Cervical Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K201671A-Link ZAcuity Surgical Devices, LLC202125—
+4K200919Idys ALIF 3DTiClariance20210—
+4K202032Idys LLIF 3DTiClariance, Sas20210—
+4K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+4K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+4K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+4K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+4K192897icotec Cervical CageIcotec AG20201—
+4K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+4K191134IB3D AlifMedicrea International SA20191—
+4K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+4K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K191263Idys ALIF TiVacClariance, Sas20190—
+4K161379ELSA SpacersGlobus Medical, Inc.2016155—
+5K263049SABER-C SystemElevation Spine20260—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+5K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K253331PressON Spinal Fixation SystemNexus Spine20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+5K243188Cylox® STSignus Medizintechnik GmbH20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+5K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+5K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+5K240368E3D™-A Interbody SystemEvolution Spine20247—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+5K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+5K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+5K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+5K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+5K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+5K223326Axiom PSR SystemRestor3D202301
+5K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+5K222561AlignAcuity Surgical Devices, LLC202214—
+5K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+5K220610SOLO-LAurora Spine, Inc.20220—
+5K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+5K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+5K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+5K212562Idys-C ZP 3DTiClariance, SA20211—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+5K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+5K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+5K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+5K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+5K200316UNiD IB3D ALIFMedicrea International SA20200—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+5K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+5K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+5K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+5K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+5K181397DualXInnovasive, Inc.201815—
+5K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+5K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+6K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—