510(k) Report

Devices descending from K083310

40 later devices reach Spine & Trauma Ict through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183605Spine & Trauma NavigationBrainlab AG2019253
+1K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+1K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+2K242271Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.20240—
+2K220554Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.20220—
+2K212245Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection…Brainlab AG202215—
+2K203679Automatic RegistrationBrainlab AG20211—
+2K202320CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic…Brainlab AG20209—
+2K201661Symphony Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL20207—
+2K201006K2M Navigation InstrumentsK2m, Inc.20200—
+2K192911Brainlab Compatible K2M Navigation InstrumentsK2m, Inc.20199—
+2K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC20160—
+3K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+3K260240SYMPHONY Navigation Ready InstrumentsMedos International SARL20260—
+3K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemPoint Robotics MedTech, Inc.20260—
+3K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+3K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+3K234047Automatic RegistrationBrainlab AG20240—
+3K223553Spine Planning (2.0), Elements Spine Planning, Elements Planning SpineBrainlab AG20231—
+3K222966Cirq Arm System (2.0);Alignment System SpineBrainlab AG202201
+3K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Brainlab AG20226—
+3K212756Discectomy Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL20225—
+3K203205Navigated Spine InstrumentsStryker Spine20218—
+4K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE20260—
+4K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+4K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—
+4K252562Spine & Trauma Navigation InstrumentsBrainlab AG20250—
+4K242569Mixed Reality Spine NavigationBrainlab AG20250—
+4K233254TELIGEN System Navigation Ready InstrumentsDePuy Synthes20242—
+4K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+4K240701Drill Guide; Drill Bit; Spine & Trauma NavigationBrainlab AG20240—
+4K223108TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)Medos International SARL20234—
+5K260546Q Pedicle InstrumentsK2m, Inc.20260—
+5K252873Q Interbody InstrumentsK2m, Inc.20260—
+5K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+5K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+5K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL20230—
+6K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+6K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+6K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—