510(k) Report

Devices descending from K081730

705 later devices reach Novel Cervical Spinal Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+7K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+7K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+7K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+7K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+7K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+7K181397DualXInnovasive, Inc.201815—
+7K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+7K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+7K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+8K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K261279DeltaNEC Interbody SystemNexus Spine20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+8K253545Vulcan Spinal SystemK2m, Inc.20260—
+8K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+8K252742Navigated InstrumentsTyber Medical, LLC20251—
+8K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+8K252322SIros-X SystemGenesys Spine20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+8K250556Porous Biologic ScaffoldVentris Medical20250—
+8K243188Cylox® STSignus Medizintechnik GmbH20250—
+8K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+8K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+8K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+8K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+8K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+8K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+8K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+8K240458Synthetic Bone PuttyVentris Medical20242—
+8K240459Cerament Bone Void FillerBonesupport AB20240—
+8K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+8K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+8K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+8K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+8K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+8K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+8K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+8K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+8K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+8K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+8K211740DualXAmplify Surgical, Inc.20211—
+8K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+8K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+8K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+8K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+8K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+8K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+8K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+8K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+8K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+8K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+9K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K243474MagnetOs MISKuros Biosciences B.V20250—
+9K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+9K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+9K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+9K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+9K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+9K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+9K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+9K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+9K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+9K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+9K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+9K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+9K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+9K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+9K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+10K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+10K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+10K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+10K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+10K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+10K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+10K230989Rod Registration FrameNu Vasive, Incorporated20230—
+10K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—