510(k) Report

Devices descending from K111019

51 later devices reach Surgimap (TM) Spine through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211386MySpine WebPlanner & MyBalanceMedacta International S.A.20211—
+1K163221Mazor XMazor Robotics, Ltd.201719—
+1K142648SPINEDESIGN Spine Surgery Planning (Software Application)Medtronic Sofamor Danek USA, Inc.20150—
+1K141669SurgimapNemaris, Inc.201427—
+2K261861SPINEsim v1.0Mdsim S.A.20260—
+2K251532Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20250—
+2K243697MySpine WebPlannerMedacta International S.A.20250—
+2K230252OFIX MIS AppOrthofix US, LLC20230—
+2K223841KBA3DS.M.A.I.O20231—
+2K221796Cyware 4H and Cysart 4HAbys Medical20221—
+2K213975KEOPS Balance Analyzer 3DS.M.A.I.O20222—
+2K211987ATEC Alignment AppAlphatec Spine, Inc.20212—
+2K180307Mazor XMazor Robotics, Ltd.201817—
+2K172522Mazor XMazor Robotics, Ltd.20170—
+2K171617OKI Surgical Planning SoftwareOrtho Kinematics, Inc.20171—
+2K170172UNiD Spine AnalyzerMedicrea International20177—
+2K162647NuVasive NuvaLine Mobile AppNu Vasive, Incorporated20174—
+2K160407spineEOSOnefit Medical20166—
+3K261500KBA3D (v2.4.0)S.M.A.I.O20260—
+3K243069Lumys (V1)Intradys20250—
+3K240199IntraOp Alignment SystemAlphatec Spine, Inc.20241—
+3K232086spineEOSEos Imaging20235—
+3K192435NuVasive NuvaLineNu Vasive, Incorporated20190—
+3K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+3K180091UNiD Spine AnalyzerMedicrea International20186—
+3K173247Surgical Planning Software version 1.1Ortho Kinematics, Inc.20170—
+4K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+4K240582VEA Align; spineEOSEos Imaging20244—
+4K212005UNiD Spine AnalyzerMedicrea International, Inc.202221
+4K200935Mazor XMazor Robotics, Ltd.202015—
+5K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20251—
+5K251747VEA Align; spineEOSEos Imaging20251—
+5K251629UNiD™ Spine AnalyzerMedicrea International S.A.S. (Medtronic)20251—
+5K203005Mazor XMazor Robotics, Ltd.2020141
+6K260322Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20260—
+6K261289UNiD™ Spine Analyzer (SW3002)Medicrea International S.A.S. (Medtronic)20260—
+6K251078AutoDensityEos Imaging20250—
+6K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+6K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+7K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+7K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+7K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+8K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+9K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—