510(k) Report

Devices descending from K032033

1,106 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K202771CD Horizon Spinal SystemMedtronic202021—
+4K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+4K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+4K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+4K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+4K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+4K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+4K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+4K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+4K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+4K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+4K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+4K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+4K193219G Surgical Marksman SystemG Surgical, LLC20191—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+4K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+4K183381Navigation Enabled InstrumentsStryker20191—
+4K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+4K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+4K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+4K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K181188EVEREST Spinal SystemK2m, Inc.20186—
+4K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+4K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+4K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+4K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+4K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K171582NEO Pedicle Screw System™Neo Medical SA20170—
+4K171321K2M Navigation InstrumentsK2m201711
+4K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+4K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+4K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+4K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+4K162786PASS LP Spinal SystemMedicrea International SA20176—
+4K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+4K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+4K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+4K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+4K161842Overwatch Spine SystemAmendia, Inc.201661
+4K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+4K161379ELSA SpacersGlobus Medical, Inc.2016155—
+4K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+4K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—
+4K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+4K161627PASS LP Spinal SystemMedicrea International SA20167—
+4K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+4K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation201660—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+4K160003Sniper (R) Spine SystemSpine Wave, Inc.20167—
+4K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+4K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+4K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+4K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+4K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+4K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K151216Everest Spinal SystemK2m, Inc.201511—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+4K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+4K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+4K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+4K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+4K142360Everest Spinal SystemK2m, Inc.201522—
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—
+4K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.2014286—
+4K141044M.U.S.T. ExtensionMedacta International201416—
+4K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+4K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+4K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+4K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+4K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—