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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 K172572
Device Name Stryker Upper-Face AXS screws and Mid-Face AXS screws
Applicant
Stryker
750 Trade Centre Way -Suite 200
Portage,  MI  49002
Applicant Contact Jonathan Schell
Correspondent
Stryker
750 Trade Centre Way -Suite 200
Portage,  MI  49002
Correspondent Contact Jonathan Schell
Regulation Number872.4760
Classification Product Code
JEY  
Date Received08/28/2017
Decision Date 10/31/2017
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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