510(k) Report

Devices descending from K141669

27 later devices reach Surgimap through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261861SPINEsim v1.0Mdsim S.A.20260—
+1K251532Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20250—
+1K230252OFIX MIS AppOrthofix US, LLC20230—
+1K223841KBA3DS.M.A.I.O20231—
+1K221796Cyware 4H and Cysart 4HAbys Medical20221—
+1K213975KEOPS Balance Analyzer 3DS.M.A.I.O20222—
+1K211987ATEC Alignment AppAlphatec Spine, Inc.20212—
+1K171617OKI Surgical Planning SoftwareOrtho Kinematics, Inc.20171—
+1K170172UNiD Spine AnalyzerMedicrea International20177—
+1K162647NuVasive NuvaLine Mobile AppNu Vasive, Incorporated20174—
+1K160407spineEOSOnefit Medical20166—
+2K261500KBA3D (v2.4.0)S.M.A.I.O20260—
+2K243069Lumys (V1)Intradys20250—
+2K240199IntraOp Alignment SystemAlphatec Spine, Inc.20241—
+2K232086spineEOSEos Imaging20235—
+2K192435NuVasive NuvaLineNu Vasive, Incorporated20190—
+2K180091UNiD Spine AnalyzerMedicrea International20186—
+2K173247Surgical Planning Software version 1.1Ortho Kinematics, Inc.20170—
+3K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+3K240582VEA Align; spineEOSEos Imaging20244—
+3K212005UNiD Spine AnalyzerMedicrea International, Inc.202221
+4K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20251—
+4K251747VEA Align; spineEOSEos Imaging20251—
+4K251629UNiD™ Spine AnalyzerMedicrea International S.A.S. (Medtronic)20251—
+5K260322Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20260—
+5K261289UNiD™ Spine Analyzer (SW3002)Medicrea International S.A.S. (Medtronic)20260—
+5K251078AutoDensityEos Imaging20250—