510(k) Report

Devices descending from K241171

4 later devices reach Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+1K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+1K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—
+2K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—