510(k) Report

Devices descending from K031590

136 later devices reach Sectra Orthopedic Package through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K240582VEA Align; spineEOSEos Imaging20244—
+6K221432Customize3D-Side S.A.20220—
+6K212040RI.Hip ModelerBlue Belt Technologies, Inc.20223—
+6K212005UNiD Spine AnalyzerMedicrea International, Inc.202221
+6K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+6K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+6K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+7K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20251—
+7K251747VEA Align; spineEOSEos Imaging20251—
+7K251629UNiD™ Spine AnalyzerMedicrea International S.A.S. (Medtronic)20251—
+7K251096PeekMed webPeek Health, S.A.20253—
+7K243447Rapid Surgical Plan (RSP-SW-001)Navbit Pty, Ltd.20240—
+7K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+7K200935Mazor XMazor Robotics, Ltd.202015—
+8K260322Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20260—
+8K261289UNiD™ Spine Analyzer (SW3002)Medicrea International S.A.S. (Medtronic)20260—
+8K252856PeekMed webPeek Health, S.A.20251—
+8K251078AutoDensityEos Imaging20250—
+8K252452PeekMed webPeek Health, S.A.20250—
+8K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+8K203005Mazor XMazor Robotics, Ltd.2020141
+9K261641Lower Limb AI (LLAI)AI Planning Logic, Inc.20260—
+9K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+9K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+10K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+10K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+10K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+10K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+10K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+11K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+11K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+11K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+11K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+11K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+12K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+12K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—