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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 K183172
Device Name Stryker SternalPlate System
Applicant
Stryker
750 Trade Centre Way
Suite 200
Portage,  MI  49002
Applicant Contact Hans Geiger
Correspondent
Stryker
750 Trade Centre Way
Suite 200
Portage,  MI  49002
Correspondent Contact Hans Geiger
Regulation Number888.3030
Classification Product Code
HRS  
Date Received11/16/2018
Decision Date 03/05/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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