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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 K191916
Device Name Stryker CMF MEDPOR Priority Customized Implant Kit
Applicant
Stryker Leibinger GmbH & Co KG
Boetzinger Strasse 41
D-79111
Freiburg,  DE
Applicant Contact Gregory Gohl
Correspondent
Stryker Leibinger GmbH & Co KG
Boetzinger Strasse 41
D-79111
Freiburg,  DE
Correspondent Contact Gregory Gohl
Regulation Number878.3550
Classification Product Code
FWP  
Date Received07/17/2019
Decision Date 08/15/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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