510(k) Report

Devices descending from K211490

5 later devices reach Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model… 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—
+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—
+3K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—