510(k) Report

Devices descending from K192911

9 later devices reach Brainlab Compatible K2M Navigation Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203205Navigated Spine InstrumentsStryker Spine20218—
+2K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+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—
+3K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+4K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+4K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+4K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—