510(k) Report

Devices descending from K082236

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+1K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+1K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+1K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+1K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+1K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+1K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+1K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20096561
+1K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009776—
+2K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+2K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+2K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+2K220486Kentrospine PSS Pedicle Screw SystemRivarp Medical Private Limited20220—
+2K221244CD Horizon™ Spinal SystemMedtronic202220—
+2K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+2K201457Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemAuxein Medical Private Limited/7116420212—
+2K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+2K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+2K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+2K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+2K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+2K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+2K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+2K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+2K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+2K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+2K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+2K142499Reline SystemNu Vasive, Incorporated201478—
+2K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+2K141494CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014273—
+2K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+2K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+2K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+2K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+2K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+2K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+2K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+2K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011597—
+2K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+2K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+2K101971Syntec OS Spinal Fixation SystemSyntec Scientific Corp.20110—
+2K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010598—
+2K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517—
+2K092325Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20093—
+3K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+3K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+3K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+3K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+3K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+3K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+3K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+3K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+3K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+3K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+3K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+3K223494CD Horizon Spinal SystemMedtronic202317—
+3K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+3K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+3K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+3K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+3K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+3K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+3K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+3K210637CD Horizon™ Spinal SystemMedtronic202134—
+3K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+3K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+3K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+3K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+3K202771CD Horizon Spinal SystemMedtronic202021—
+3K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+3K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+3K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+3K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+3K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+3K191575ARx Spinal SystemLife Spine, Inc.201910—
+3K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+3K183381Navigation Enabled InstrumentsStryker20191—
+3K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+3K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+3K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+3K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+3K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+3K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+3K172469TiLock Modular Spinal SystemGenesys Spine20170—
+3K171321K2M Navigation InstrumentsK2m201711
+3K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+3K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+3K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+3K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+3K161842Overwatch Spine SystemAmendia, Inc.201661