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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 K123569
Device Name ANTEGRADE FEMORAL NAIL
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 Received11/20/2012
Decision Date 05/24/2013
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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