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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K243491
Device Name SternalPlate Expansion
Applicant
Stryker Leibinger GmbH & Co. KG
Boetzinger Strasse 41
Freiburg,  DE D-79111
Applicant Contact Amelia Kesti
Correspondent
Stryker Leibinger GmbH & Co. KG
Boetzinger Strasse 41
Freiburg,  DE D-79111
Correspondent Contact Amelia Kesti
Regulation Number888.3030
Classification Product Code
HRS  
Date Received11/12/2024
Decision Date 12/11/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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