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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K110322
Device Name OLECRA INTRAMEDULLARY FIXATION SYSTEM
Applicant
Mylad Orthopedic Solutions
8803 Windy Creek Way
Mclean,  VA  22102
Applicant Contact SCOTT G EDWARDS
Correspondent
Mylad Orthopedic Solutions
8803 Windy Creek Way
Mclean,  VA  22102
Correspondent Contact SCOTT G EDWARDS
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Code
NDE  
Date Received02/03/2011
Decision Date 03/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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