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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K151762
Device Name PediatrOS RigidTack/FlexTack
Applicant
MERETE MEDICAL GMBH
ALT-LANKWITZ 102
BERLIN,  DE 12247
Applicant Contact EMMANUEL ANAPLIOTIS
Correspondent
MERETE MEDICAL, INC.
4 CROTTY LANE, SUITE 118
NEW YORK INTERNATIONAL PLAZA
NEW WINDSOR,  NY  12553
Correspondent Contact Matthias Möllmann
Regulation Number888.3030
Classification Product Code
JDR  
Subsequent Product Code
OBT  
Date Received06/29/2015
Decision Date 12/28/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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