510(k) Report

Devices descending from K141941

22 later devices reach Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221028SURGIVISIO DeviceEcential Robotics20227—
+1K183196Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers…Stryker Corporation20190—
+1K172034Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock…Stryker Corporation201712—
+2K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+2K231886SURGIVISIO DeviceEcential Robotics20236—
+2K220593Spine Guidance Software, Stryker Q Guidance SystemStryker Leibinger GmbH & Co KG202210—
+2K203205Navigated Spine InstrumentsStryker Spine20218—
+3K260546Q Pedicle InstrumentsK2m, Inc.20260—
+3K252873Q Interbody InstrumentsK2m, Inc.20260—
+3K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+3K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+3K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+3K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+3K223767Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho…Stryker Leibinger GmbH & Co KG20231—
+4K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+4K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+4K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+4K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+4K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+4K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—
+4K233542Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho…Stryker Leibinger GmbH & Co KG20240—
+5K254158SPINEART Navigation Instrument SystemSpineart SA20261—