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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
510(k) Number K112345
Device Name DISTAL VOLAR RADIUS PLATING SYSTEMS
Applicant
Medos International SARL
700 Orthopaedic Dr.
Warsaw,  IN  46581
Applicant Contact SUZANA OTANO
Correspondent
Medos International SARL
700 Orthopaedic Dr.
Warsaw,  IN  46581
Correspondent Contact SUZANA OTANO
Regulation Number888.3030
Classification Product Code
LXT  
Date Received08/15/2011
Decision Date 10/31/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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