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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 K093206
Device Name ORTHOMAP 3D 1.1 MODULE
Applicant
STRYKER CORP.
BOTZINGER STRABE 41
FREIBURG,  DE D-79111
Applicant Contact LILIAN ECKERT
Correspondent
STRYKER CORP.
BOTZINGER STRABE 41
FREIBURG,  DE D-79111
Correspondent Contact LILIAN ECKERT
Regulation Number882.4560
Classification Product Code
OLO  
Date Received10/13/2009
Decision Date 08/04/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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