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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 K170725
Device Name Stryker Universal Mesh
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 Number882.5320
Classification Product Code
GWO  
Date Received03/09/2017
Decision Date 11/13/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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