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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 K091798
Device Name MERETE COMPRESSION SCREWS
Applicant
Merete Medical GmbH
49 Purchase St.
Rye,  NY  10580
Applicant Contact JORG MIETZNER
Correspondent
Merete Medical GmbH
49 Purchase St.
Rye,  NY  10580
Correspondent Contact JORG MIETZNER
Regulation Number888.3040
Classification Product Code
HWC  
Date Received06/17/2009
Decision Date 09/02/2009
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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