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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Threaded
510(k) Number K102777
Device Name TWISTCUT ENDOSORB SCREWS
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 Number888.3040
Classification Product Code
JDW  
Subsequent Product Code
HWC  
Date Received09/24/2010
Decision Date 12/20/2010
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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