510(k) Report

Devices descending from K062327

14 later devices reach Modification to S4 Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+2K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+2K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC20160—
+3K201006K2M Navigation InstrumentsK2m, Inc.20200—
+3K192911Brainlab Compatible K2M Navigation InstrumentsK2m, Inc.20199—
+4K203205Navigated Spine InstrumentsStryker Spine20218—
+5K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+6K260546Q Pedicle InstrumentsK2m, Inc.20260—
+6K252873Q Interbody InstrumentsK2m, Inc.20260—
+6K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+6K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+7K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+7K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+7K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—