510(k) Report

Devices descending from K081614

843 later devices reach Zeus Small Cervical Cage and Large, Extra Large, Curved and Straight Lumbar… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+1K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+1K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+1K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+1K150847Foundation Interbody DevicesCorelink, LLC201529—
+1K140280ForticoreNanovis, LLC20149—
+1K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+1K100889Endoskeleton TCTitan Spine, LLC2010455—
+1K090064Eminent Spine Interbody Fusion SystemEminent Spine20097011
+2K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+2K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+2K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+2K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+2K230219Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC20234—
+2K212701Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine20235—
+2K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+2K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+2K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+2K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+2K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+2K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC20190—
+2K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+2K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+2K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+2K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+2K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+2K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+2K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+2K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC201801
+2K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+2K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+2K171312FortiCore®Nanovis, LLC20183—
+2K172330Blustone Synergy Silica SystemBlustone Synergy20170—
+2K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+2K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+2K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+2K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+2K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+2K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+2K163494Summit Spine Channel Cervical Interbody Fusion SystemSummit Spine20171—
+2K162496Foundation 3D InterbodyCorelink, LLC201782—
+2K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+2K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+2K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+2K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)Evolution Spine, LLC20160—
+2K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+2K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+2K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+2K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+2K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+2K160324Cervical Interbody Fusion SystemEvolution Spine, LLC20162—
+2K150812Genesys Spine Apache Cervical Interbody Fusion SystemGenesys Spine201512—
+2K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+2K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+2K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+2K142026Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.2014190—
+2K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+2K141337Arena-CSpinefrontier, Inc.20141—
+2K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+2K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+2K130317Genesys Spine Apache Ibfd Star Cervical SystemGenesys Spine20139—
+2K133126K7 Lumbar SpacersK7, LLC20131—
+2K132718Integrity Spine Core SystemIntegrity Spine20131—
+2K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+2K121178Transcorp Acif SystemTranscorp, Inc.20130—
+2K131372Mobis IISignus Medizintechnik GmbH2013462—
+2K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+2K123969XiphosDifusion Technologies201314—
+2K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454—
+2K123388K7C SpacerK7, LLC20130—
+2K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+2K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+2K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+2K113518Arena-C Cervical Intervertebral Body Fusion SystemSpinefrontier, Inc.2012193—
+2K112862Mecta-CMedacta International201114—
+2K110659Medical Concepts Interbody Fusion SystemMedical Concepts, Inc.20111—
+2K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+2K110177Helena SystemRoyal Oak Medical Devices20110—
+2K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+3K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+3K253260ORIO-3D Cage SystemSpineCraft20260—
+3K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+3K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+3K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+3K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+3K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+3K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+3K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+3K230329F3D Interbody SystemCorelink, LLC20230—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+3K223043The Integrity Spine Core SystemIntegrity Spine20230—