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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K081097
Device Name ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
Applicant
Orthopediatrics, LLC
210 N. Buffalo St.
Warsaw,  IN  46580
Applicant Contact GARY BARNETT
Correspondent
Orthopediatrics, LLC
210 N. Buffalo St.
Warsaw,  IN  46580
Correspondent Contact GARY BARNETT
Regulation Number888.3040
Classification Product Code
HTY  
Date Received04/17/2008
Decision Date 06/03/2008
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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