510(k) Report

Devices descending from K990148

1,867 later devices reach Stackable Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K102738Lanx Fusion SystemLanx, LLC20113281
+5K101288Staxx XD SystemSpine Wave, Inc.201051
+5K082698Aleutian Ibf SystemK2m, Inc.2009662—
+5K082270Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc.200855—
+5K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20087751
+5K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.20071,405—
+5K063399Aleutian Spacer SystemK2m, Inc.2007663—
+5K060350Construx PL/TL Peek Partial VBR SystemBlackstone Medical, Inc.2006754—
+5K053292Davantis/Antelys Vertebral Body ReplacementsScient'X USA, Inc.20060—
+5K052096Nubic Spinal ImplantSignus Medical, LLC2005790—
+6K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+6K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+6K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K2530413d Cage CervicalFims Co., Ltd.20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K261279DeltaNEC Interbody SystemNexus Spine20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+6K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K261067BEE PLIF CageNGMedical GmbH20260—
+6K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+6K252774Uni-C Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+6K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+6K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+6K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K250560BEE HANGMedical GmbH20250—
+6K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+6K252742Navigated InstrumentsTyber Medical, LLC20251—
+6K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+6K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+6K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+6K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+6K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+6K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K250556Porous Biologic ScaffoldVentris Medical20250—
+6K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+6K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+6K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243670Idys® LIFClariance20240—
+6K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+6K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+6K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+6K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+6K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+6K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+6K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+6K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+6K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+6K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+6K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+6K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+6K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+6K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+6K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+6K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+6K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+6K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+6K240442MagnetOs PuttyKuros Biosciences B.V20243—
+6K234150Lucent® XPSpinal Elements20240—
+6K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+6K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+6K240458Synthetic Bone PuttyVentris Medical20242—
+6K240459Cerament Bone Void FillerBonesupport AB20240—
+6K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—