510(k) Report

Devices descending from K062640

50 later devices reach Stryker Navigation System - Cranial Module, Model 6000-650-000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142024Brightmatter Navigation SystemSynaptive Medical, Inc.2015121
+1K141551Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70 (Degrees)…Stryker Corporate2014201
+1K131214Cranial Map NeuroStryker Corporate201326—
+1K093206Orthomap 3D 1.1 ModuleStryker Corp.20100—
+1K083009Ortho-Map-Oncology Navigation Software, Models 6005-650-000, 6005-651-000Stryker Leibinger GmbH & Co KG20091—
+2K181848ADAPT for Gamma3, Gamma3Stryker GmbH20181—
+2K1810417D Surgical System Cranial Application7D Surgical, Inc.20186—
+2K162929Stryker Navigation System with CranialMap software application, Stryker CranialMap…Stryker Corporation20173—
+2K153240Styrker OrthoMap Express Knee SystemStryker Corporate201617—
+2K160523BrightMatter Guide with BrightMatter PointerSynaptive Medical, Inc.20160—
+2K151156Fiagon Navigation SystemFiagon GmbH20161—
+2K153281BrightMatter Guide with Surface Trace RegistrationSynaptive Medical, Inc.20162Class I
+2K141941Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap 3D…Stryker Corporate201422—
+3K223288Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial…Brainlab AG20230—
+3K212194Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and…Stryker Corporation202312
+3K223767Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho…Stryker Leibinger GmbH & Co KG20231—
+3K221028SURGIVISIO DeviceEcential Robotics20227—
+3K202749ADAPT for Gamma3Stryker GmbH20200—
+3K1929457D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application7D Surgical, Inc.20195—
+3K183325Modus NavSynaptive Medical, Inc.20190—
+3K183196Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers…Stryker Corporation20190—
+3K172034Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock…Stryker Corporation201712—
+3K163209Fiagon Navigation SystemFiagon GmbH20170—
+3K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG201616—
+4K242480FLASH EVD System (10-0002)7D Surgical ULC20240—
+4K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+4K233542Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho…Stryker Leibinger GmbH & Co KG20240—
+4K230661Zeta Cranial Navigation SystemZeta Surgical20233—
+4K231886SURGIVISIO DeviceEcential Robotics20236—
+4K220593Spine Guidance Software, Stryker Q Guidance SystemStryker Leibinger GmbH & Co KG202210—
+4K213380360CASKico Knee Innovation Company Pty Limited20222—
+4K203205Navigated Spine InstrumentsStryker Spine20218—
+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—
+5K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+5K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K233903Zeta Cranial Navigation System (ZNS131-US)Zeta Surgical, Inc.20242—
+5K223927360CASKico Knee Innovation Company Pty Limited20231—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+6K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+6K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+6K242351Zeta Cranial Navigation System (ZNS131-US)Zeta Surgical, Inc.20241—
+6K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—
+6K242009360CAS KneeKico Knee Innovation Company Pty, Ltd.20240—
+7K253663Zeta Navigation SystemZeta Surgical, Inc.20260—
+7K254158SPINEART Navigation Instrument SystemSpineart SA20261—