510(k) Report

Devices descending from K011508

714 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043321Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek20050—
+1K041460CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2004712—
+2K241663Eminent Spine 3D Titanium Pedicle Screw SystemEminent Spine20250—
+2K133690True Spinal Fussion SystemInnovative Surgical Designs20140—
+2K133103Aversion Pedicle Screw SystemK7, LLC20140—
+2K130958True Spinal Fixation SystemInnovative Surgical Designs20131—
+2K120891Tangors Multifunctional Posterior SystemUlrich GmbH & Co. KG201218—
+2K120074Foundation Spinal SystemThe Skeletal Design Partnership, Ltd.20122—
+2K113173Nanovis Spinal SystemNanovis, LLC20122—
+2K111883Smartloc Spinal Fixation SystemA-Spine Asia, Co., Ltd.20112—
+2K102853Flamenco Spinal Fixation SystemUlrich GmbH & Co. KG2011221
+2K101278Inertia Pedicle Screw SystemNexxt Spine, LLC2010111—
+2K093833Kapss Spinal SystemRobert Reid, Inc.20100—
+2K100377Diamondback Spinal SystemEminent Spine201029—
+2K042167Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004658—
+3K252730Fule Spinal Fixation SystemBeijing Fule Science & Technology Development Co., Ltd.20250—
+3K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K203452Nano FortiFix® SystemNanovis, LLC20200—
+3K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+3K180301AXIS 5.5 Lumbar Pedicle Screw SystemAxis Orthopaedics20180—
+3K180324Patriot Spinal Fixation SystemValorus Spine20180—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K142655CB PROT II Posterior Spinal SystemChin Bone Technique Corp20150—
+3K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+3K132412Inertia Mis Pedicle Screw SystemNexxt Spine, LLC2013107—
+3K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+3K123717UcentumUlrich GmbH & Co. KG2013171
+3K111301Instinct Java SystemZimmer Spine201131
+3K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20096561
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K221244CD Horizon™ Spinal SystemMedtronic202220—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+4K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+4K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+4K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+4K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+4K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+4K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+4K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+4K141494CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014273—
+4K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+4K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+4K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+4K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+4K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+4K123552Instinct Java SystemZimmer Spine201301
+4K122592Instinct Java SystemZimmer Spine201301
+4K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+4K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+4K113270Instinct Java SystemZimmer Spine201121
+4K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+4K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011597—
+4K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+4K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+4K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010598—
+4K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517—
+5K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+5K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+5K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+5K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+5K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+5K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K223494CD Horizon Spinal SystemMedtronic202317—
+5K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+5K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+5K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+5K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+5K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K210637CD Horizon™ Spinal SystemMedtronic202134—
+5K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+5K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+5K202771CD Horizon Spinal SystemMedtronic202021—
+5K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+5K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+5K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+5K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—