K240662 - Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece
(FDA 510(k) Clearance)

K240662 is an FDA 510(k) clearance for the Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Stryker Leibinger GmbH & Co KG (Freiburg Im Breisgau, DE). The FDA issued a Cleared decision on June 6, 2024, 90 days after receiving the submission on March 8, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.