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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K171364
Device Name MP LeFort I Plates
Applicant
Stryker
750 Trade Centre Way
Suite 200
Portage,  MI  49002
Applicant Contact Gregory Gohl
Correspondent
Stryker
750 Trade Centre Way
Suite 200
Portage,  MI  49002
Correspondent Contact Gregory Gohl
Regulation Number872.4760
Classification Product Code
JEY  
Date Received05/09/2017
Decision Date 07/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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