510(k) Report

Devices descending from K112593

20 later devices reach Styker Consolidated Operating Room Equipment (Core) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+1K171840Stryker Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Corporation20178—
+1K143399Stryker Footed Attachments and Cutting AccessoriesStryker Corp.201511
+1K143540Stryker MIS Attachments and Cutting AccessoriesStryker Corporation20154—
+1K143320Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsStryker Corp.201567
+1K141935Stryker S2 DrillStryker Corporation20147—
+2K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+2K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+2K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—
+2K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+2K210377Stryker iBur hubs and cutting accessoriesStryker Corporation2021110
+2K191049Stryker MIS and Footed AttachmentsStryker Corporation20190—
+2K190172Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsStryker20195—
+2K153519DRealCarevature Medical, Ltd.20160—
+2K152641Pi Drive Plus Motor, ExtenderStryker Corporation20156—
+3K260546Q Pedicle InstrumentsK2m, Inc.20260—
+3K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+3K252873Q Interbody InstrumentsK2m, Inc.20260—
+3K250374iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round…Stryker Instruments20250—
+3K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number…Stryker Corporation20215—