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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Chin, Internal
510(k) Number K153508
Device Name Stryker CMF MEDPOR Customized Implant
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 Number878.3550
Classification Product Code
FWP  
Date Received12/07/2015
Decision Date 02/05/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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