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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 K103533
Device Name ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM
Applicant
Advanced Orthopaedic Solutions, Inc.
386 Beech Ave.
Unit B6
Torrance,  CA  90501
Applicant Contact JULIE GLENDRANGE
Correspondent
Advanced Orthopaedic Solutions, Inc.
386 Beech Ave.
Unit B6
Torrance,  CA  90501
Correspondent Contact JULIE GLENDRANGE
Regulation Number888.3020
Classification Product Code
HSB  
Date Received12/01/2010
Decision Date 01/19/2011
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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