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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 K143597
Device Name Navigated XIA 4.5 Polyaxial Screwdriver
Applicant
STRYKER CORPORATE
BOETZINGER STR.41
FREIBURG,  DE 79111
Applicant Contact BECKY DITTY
Correspondent
STRYKER CORPORATE
4100 E. MILHAM AVE
KALAMAZOO,  MI  49001
Correspondent Contact BECKY DITTY
Regulation Number882.4560
Classification Product Code
OLO  
Date Received12/18/2014
Decision Date 09/04/2015
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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