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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 K083726
Device Name PEDINAIL INTRAMEDULLARY NAILING SYSTEM
Applicant
ORTHOPEDIATRICS, CORP.
210 N. BUFFALO ST.
WARSAW,  IN  46580
Applicant Contact GARY BARNETT
Correspondent
ORTHOPEDIATRICS, CORP.
210 N. BUFFALO ST.
WARSAW,  IN  46580
Correspondent Contact GARY BARNETT
Regulation Number888.3020
Classification Product Code
HSB  
Date Received12/15/2008
Decision Date 03/11/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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