510(k) Report

Devices descending from K183605

25 later devices reach Spine & Trauma Navigation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242271Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.20240—
+1K220554Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.20220—
+1K212245Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection…Brainlab AG202215—
+1K203679Automatic RegistrationBrainlab AG20211—
+1K202320CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic…Brainlab AG20209—
+1K201661Symphony Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL20207—
+2K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+2K260240SYMPHONY Navigation Ready InstrumentsMedos International SARL20260—
+2K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemPoint Robotics MedTech, Inc.20260—
+2K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+2K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+2K234047Automatic RegistrationBrainlab AG20240—
+2K223553Spine Planning (2.0), Elements Spine Planning, Elements Planning SpineBrainlab AG20231—
+2K222966Cirq Arm System (2.0);Alignment System SpineBrainlab AG202201
+2K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Brainlab AG20226—
+2K212756Discectomy Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL20225—
+3K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE20260—
+3K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+3K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—
+3K252562Spine & Trauma Navigation InstrumentsBrainlab AG20250—
+3K242569Mixed Reality Spine NavigationBrainlab AG20250—
+3K233254TELIGEN System Navigation Ready InstrumentsDePuy Synthes20242—
+3K240701Drill Guide; Drill Bit; Spine & Trauma NavigationBrainlab AG20240—
+3K223108TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)Medos International SARL20234—
+4K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL20230—