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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K241517
Device Name Q Guidance System; Mako Spine System;
Applicant
Stryker Leibinger GmbH & Co KG
Bötzinger Straße 41
Freiburg Im Breisgau,  DE D-79111
Applicant Contact Dipan Lad
Correspondent
Stryker Leibinger GmbH & Co KG
Bötzinger Straße 41
Freiburg Im Breisgau,  DE D-79111
Correspondent Contact Dipan Lad
Regulation Number882.4560
Classification Product Code
OLO  
Date Received05/29/2024
Decision Date 08/27/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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