510(k) Report

Devices descending from K041203

657 later devices reach Summit Oct Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K222789VADER® Pedicle System, G21 CementIcotec AG202352
+6K223273ASTRA Spine SystemSpinecraft, LLC20228—
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+6K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+6K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K221244CD Horizon™ Spinal SystemMedtronic202220—
+6K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+6K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K211323ASTRA Spine SystemSpinecraft, LLC202112—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K203205Navigated Spine InstrumentsStryker Spine20218—
+6K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+6K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+6K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+6K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+6K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+6K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+6K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+6K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+6K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+6K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+6K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+6K172115Navigated Instrument SystemOrthofix, Inc.20184—
+6K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+6K172194Connector SystemOrthofix, Inc.2017162
+6K162921Navigated Instrument SystemOrthofix, Inc.20175—
+6K162786PASS LP Spinal SystemMedicrea International SA20176—
+6K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+6K161028K2M Growing Spine SystemK2m, Inc.20163—
+6K161369EVEREST Spinal SystemK2m, Incorporated20169—
+6K153439PathLoc-C Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20160—
+6K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+6K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+6K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+6K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+6K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K243249TriALTIS™ Spine SystemMedos International SARL20250—
+7K243693NEO Pedicle Screw System™Neo Medical SA20240—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+7K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K232628VADER® Pedicle SystemIcotec AG20241—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K233684TriALTIS™ Spine SystemMedos International SARL20234—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+7K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K223494CD Horizon Spinal SystemMedtronic202317—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+7K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K190751Connector SystemOrthofix, Inc.20193—
+7K181188EVEREST Spinal SystemK2m, Inc.20186—
+7K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+7K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+7K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+7K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+7K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+8K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+8K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K260546Q Pedicle InstrumentsK2m, Inc.20260—
+8K252873Q Interbody InstrumentsK2m, Inc.20260—
+8K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+8K253331PressON Spinal Fixation SystemNexus Spine20250—