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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 K241171
Device Name Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories
Applicant
Stryker Leibinger GmbH & Co KG
Botzinger Strasse 39-41
Freiburg Baden-Wurttemberg,  DE D-79111
Applicant Contact John Chesney
Correspondent
Stryker Leibinger GmbH & Co KG
Botzinger Strasse 39-41
Freiburg Baden-Wurttemberg,  DE D-79111
Correspondent Contact John Chesney
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Codes
ERL   HBE   HWE  
Date Received04/26/2024
Decision Date 07/25/2024
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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