510(k) Report

Devices descending from K043343

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+6K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+6K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+6K142360Everest Spinal SystemK2m, Inc.201522—
+6K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+6K141284Caspian Spinal SystemK2m, Inc.20140—
+6K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+6K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+6K131833Centurion Poct SystemOrthofix, Inc.20142—
+6K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+6K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+6K120998Solstice Cross ConnectorLife Spine20121—
+7K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+7K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+7K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+7K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+7K252322SIros-X SystemGenesys Spine20250—
+7K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+7K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+7K243249TriALTIS™ Spine SystemMedos International SARL20250—
+7K243693NEO Pedicle Screw System™Neo Medical SA20240—
+7K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K241258Ingenix Spinal SystemIngenium Spine20240—
+7K240526POWEReam Xia/SerratoStryker Instruments20240—
+7K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+7K233684TriALTIS™ Spine SystemMedos International SARL20234—
+7K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+7K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+7K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+7K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K223273ASTRA Spine SystemSpinecraft, LLC20228—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+7K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K222698CUVIS-spineCurexo, Inc.20220—
+7K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+7K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+7K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+7K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+7K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+7K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+7K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+7K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+7K200896Solstice CCILife Spine, Inc.20200—
+7K193129Yukon OCT Spinal SystemK2m, Inc.202001
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+7K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+7K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+7K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+7K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+7K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+7K182470Plateau Spacer SystemLife Spine20180—
+7K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+7K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+7K180433Ennovate®Aesculap Implant Systems, LLC201811
+7K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+7K172194Connector SystemOrthofix, Inc.2017162
+7K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+7K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+7K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+7K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+7K161149PASS OCT Spinal SystemMedicrea International SA20160—
+7K160756PASS OCT Spinal SystemMedicrea International SA20160—
+7K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+7K153169PASS OCT Patient Specific RodsMedicrea International20164—
+7K152211PCT SystemCentinel Spine, Inc.20150—
+7K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+7K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+8K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+8K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—