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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 K132226
Device Name METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT
Applicant
Merete Medical GmbH
102 Alt Lankwitz
Berlin,  DE D-12247
Applicant Contact EMMANUEL ANAPLIOTIS
Correspondent
Merete Medical GmbH
102 Alt Lankwitz
Berlin,  DE D-12247
Correspondent Contact EMMANUEL ANAPLIOTIS
Regulation Number888.3030
Classification Product Code
HRS  
Date Received07/17/2013
Decision Date 08/09/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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