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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 K220593
Device Name Spine Guidance Software, Stryker Q Guidance System
Applicant
Stryker Leibinger GmbH & Co KG
Bötzinger Straße 41
Freiburg,  DE D-79111
Applicant Contact Andrea Wallen-Gerding
Correspondent
Stryker Leibinger GmbH & Co KG
Bötzinger Straße 41
Freiburg,  DE D-79111
Correspondent Contact Andrea Wallen-Gerding
Regulation Number882.4560
Classification Product Code
OLO  
Date Received03/01/2022
Decision Date 05/27/2022
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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