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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K150301
Device Name NavSuite3 Kit
Applicant
Stryker Leibinger GmbH & Co. KG - Navigation
Boetzinger Strasse 41
Freiburg,  DE D-79111
Applicant Contact Robin L Rowe
Correspondent
Stryker Leibinger GmbH & Co. KG - Navigation
Boetzinger Strasse 41
Freiburg,  DE D-79111
Correspondent Contact Robin L Rowe
Regulation Number882.4560
Classification Product Code
HAW  
Subsequent Product Code
OLO  
Date Received02/06/2015
Decision Date 07/08/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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