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

510(k) number: K240662
Device name: 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
Applicant: Stryker Leibinger GmbH & Co KG DE
Product code: OLO — Orthopedic Stereotaxic Instrument
Decision date: 2024-06-06
Date received: 2024-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Neurology

PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain

Also available from FDA: K240662.pdf

Official FDA record: K240662

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.