510(k) Report

Devices descending from K020995

321 later devices reach Efilm Workstation with Modules through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K261641Lower Limb AI (LLAI)AI Planning Logic, Inc.20260—
+10K253831CMN Capillary Function with Virtual Expert for MRI, CT and CBCTCercare Medical A/S20260—
+10K243350Rapid Neuro3DIschemaview, Inc.20251—
+10K231709AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4Radmedix, LLC20230—
+10K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+10K214030Universal DR 1748Konica Minolta Healthcare Americas, Inc.20221—
+10K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+11K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.20260—
+11K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+11K251987Rapid Aortic MeasurementsIschemaview, Inc.20250—
+11K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+11K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+11K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+11K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+12K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+12K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+12K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+12K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+12K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+13K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+13K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—