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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 K050924
Device Name MERETE DUOTHREADTM BONE SCREW
Applicant
Merete Medical GmbH
269 W. Seventy-First St.
New York,  NY  10023
Applicant Contact JENIK RADON
Correspondent
Merete Medical GmbH
269 W. Seventy-First St.
New York,  NY  10023
Correspondent Contact JENIK RADON
Regulation Number888.3040
Classification Product Code
HWC  
Date Received04/13/2005
Decision Date 05/27/2005
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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