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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K172213
Device Name MECRON Cannulated Screw System
Applicant
Merete GmbH
Alt-Lankwitz 102
Berlin,  DE 12247
Applicant Contact Paul Munch
Correspondent
Merete GmbH
Alt-Lankwitz 102
Berlin,  DE 12247
Correspondent Contact Paul Munch
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received07/24/2017
Decision Date 10/23/2017
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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