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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 K160548
Device Name MC-Subtalar(TM) II
Applicant
Merete Medical GmbH
Alt-Lankwitz
Berlin,  DE 12247
Applicant Contact PAUL MUNCH
Correspondent
Merete Technologies, Inc.
One Lincoln Center, 18w140 Butterfield Rd.
Oakbrook Terrace,  IL  60181
Correspondent Contact MATTHIAS MOLLMANN
Regulation Number888.3040
Classification Product Code
HWC  
Date Received02/29/2016
Decision Date 04/29/2016
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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