510(k) Report

Devices descending from K052747

528 later devices reach Modification to:CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K211323ASTRA Spine SystemSpinecraft, LLC202112—
+5K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+5K201569CUVIS-spineCurexo, Inc.20212—
+5K210306GII Spinal Fixation SystemColigne AG20210—
+5K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+5K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+5K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+5K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+5K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+5K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+5K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+5K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+5K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+5K182240PASS LP Spinal SystemMedicrea International SA20182—
+5K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+5K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+5K173126Arisstos™ Spinal SystemIngenium Spine20171—
+5K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+5K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+5K170647Connector SystemOrthofix, Inc.201718—
+5K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+5K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+5K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+5K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+5K161842Overwatch Spine SystemAmendia, Inc.201661
+5K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+5K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+5K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+5K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+5K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+5K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+5K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+5K142360Everest Spinal SystemK2m, Inc.201522—
+5K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+5K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+6K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+6K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+6K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+6K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K252322SIros-X SystemGenesys Spine20250—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+6K243249TriALTIS™ Spine SystemMedos International SARL20250—
+6K243693NEO Pedicle Screw System™Neo Medical SA20240—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K241258Ingenix Spinal SystemIngenium Spine20240—
+6K240526POWEReam Xia/SerratoStryker Instruments20240—
+6K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+6K233684TriALTIS™ Spine SystemMedos International SARL20234—
+6K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+6K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+6K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K223273ASTRA Spine SystemSpinecraft, LLC20228—
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—