510(k) Report

Devices descending from K172034

12 later devices reach Stryker Spine Navigation System with SpineMap 3D software application… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+1K220593Spine Guidance Software, Stryker Q Guidance SystemStryker Leibinger GmbH & Co KG202210—
+1K203205Navigated Spine InstrumentsStryker Spine20218—
+2K260546Q Pedicle InstrumentsK2m, Inc.20260—
+2K252873Q Interbody InstrumentsK2m, Inc.20260—
+2K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+2K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+2K223767Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho…Stryker Leibinger GmbH & Co KG20231—
+3K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+3K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+3K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—
+3K233542Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho…Stryker Leibinger GmbH & Co KG20240—