510(k) Report

Devices descending from K240662

7 later devices reach Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260546Q Pedicle InstrumentsK2m, Inc.20260—
+1K252873Q Interbody InstrumentsK2m, Inc.20260—
+1K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+1K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+2K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+2K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+2K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—