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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 K162341
Device Name Stryker OrthoMap Precision Knee system
Applicant
Stryker Leibinger GmbH & Co. KG
Boetzinger Strasse 41
Freiburg,  DE D-79111
Applicant Contact N/A N/A
Correspondent
Biologics Consulting Group, Inc.
400 N. Washington Street
Suite 100
Alexandria,  VA  22314
Correspondent Contact Calley Herzog
Regulation Number882.4560
Classification Product Code
OLO  
Date Received08/22/2016
Decision Date 10/12/2016
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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