510(k) Report

Devices descending from K080411

764 later devices reach Plateau Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+8K261067BEE PLIF CageNGMedical GmbH20260—
+8K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+8K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K253545Vulcan Spinal SystemK2m, Inc.20260—
+8K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+8K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+8K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+8K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+8K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+8K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+8K253331PressON Spinal Fixation SystemNexus Spine20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K241525ExcelsiusXR™Globus Medical, Inc.20250—
+8K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+8K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+8K243474MagnetOs MISKuros Biosciences B.V20250—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+8K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+8K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+8K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+8K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+8K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+8K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+8K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+8K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+8K240453ReBOSSISOrthorebirth Co., Ltd.202402
+8K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+8K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+8K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+8K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+8K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+8K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+8K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+8K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+8K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+8K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+8K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+8K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K221578Hexanium ACIFSpinevision, S.A.S.20224—
+8K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+8K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+8K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+8K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+8K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+8K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+8K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+8K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+8K211413BEE PLIF CageNGMedical GmbH20211—
+8K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+8K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+8K210728CONDUIT InstrumentsMedos International SARL20215—
+8K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+8K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+8K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+8K201287Impulse Interbody Fusion SystemDegen Medical20208—
+8K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+8K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+8K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+8K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+8K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+8K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+8K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+8K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+8K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+8K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+8K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+8K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+9K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+9K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+9K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+9K252742Navigated InstrumentsTyber Medical, LLC20251—
+9K252322SIros-X SystemGenesys Spine20250—