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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Cranioplasty, Preformed, Alterable
510(k) Number K121153
Device Name PEEK CUSTOMIZED CRAIAL IMPLANT KIT
Applicant
Stryker
750 Trade Centre Way
Suite 200
Portage,  MI  49002
Applicant Contact Manish Patel
Correspondent
Stryker
750 Trade Centre Way
Suite 200
Portage,  MI  49002
Correspondent Contact Manish Patel
Regulation Number882.5320
Classification Product Code
GWO  
Date Received04/16/2012
Decision Date 09/14/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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