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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 K254233
Device Name MEDPOR Customized Implant Kit
Applicant
Stryker Leibinger GmbH & Co KG
Botzinger Strasse 41
Frieburg,  DE 79111
Applicant Contact Stephani Herbert
Correspondent
Stryker Leibinger GmbH & Co KG
Botzinger Strasse 41
Frieburg,  DE 79111
Correspondent Contact Stephani Herbert
Regulation Number878.3550
Classification Product Code
FWP  
Date Received12/29/2025
Decision Date 03/12/2026
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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