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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Plate, Cranioplasty
510(k) Number K151387
Device Name Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade
Applicant
STRYKER
750 TRADE CENTRE WAY, SUITE 200
PORTAGE,  MI  49002
Applicant Contact JONATHAN SCHELL
Correspondent
STRYKER
750 TRADE CENTRE WAY, SUITE 200
PORTAGE,  MI  49002
Correspondent Contact JONATHAN SCHELL
Regulation Number882.5360
Classification Product Code
HBW  
Date Received05/26/2015
Decision Date 06/24/2015
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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