510(k) Report

Devices descending from K013962

900 later devices reach Equation Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+9K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+9K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+9K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+9K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+9K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+9K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+9K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+9K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+9K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+9K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+9K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+9K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+9K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+9K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+9K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+9K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+9K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+9K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+9K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K211740DualXAmplify Surgical, Inc.20211—
+9K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+9K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+9K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+9K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+9K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+9K201569CUVIS-spineCurexo, Inc.20212—
+9K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+9K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+9K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+9K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+9K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+9K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+9K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+9K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+9K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+9K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+9K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+9K200896Solstice CCILife Spine, Inc.20200—
+9K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+9K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+9K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+9K191217Jazz PFImplanet, S.A.20190—
+9K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+9K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+9K182182YUKON OCT Spinal SystemK2m20185—
+9K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+9K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+9K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+9K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+9K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+9K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+9K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+9K171881JAZZ Passer BandImplanet, S.A.20170—
+9K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+9K162575Z-LINKPC SystemZavation, LLC20173—
+9K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+9K150918PASS OCT Spinal SystemMedicrea International SA201513—
+9K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+9K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+9K141284Caspian Spinal SystemK2m, Inc.20140—
+9K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+9K131833Centurion Poct SystemOrthofix, Inc.20142—
+9K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+9K120998Solstice Cross ConnectorLife Spine20121—
+10K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+10K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+10K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+10K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+10K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+10K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+10K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+10K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+10K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+10K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+10K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+10K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+10K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+10K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+10K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+10K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+10K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+10K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+10K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+10K242042TriALTIS™ Spine SystemMedos International SARL20241—
+10K241846E3D™-C Interbody SystemEvolution Spine20246—
+10K240368E3D™-A Interbody SystemEvolution Spine20247—
+10K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+10K240526POWEReam Xia/SerratoStryker Instruments20240—
+10K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+10K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+10K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+10K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+10K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+10K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+10K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—