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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K100240
Device Name ORTHOPEDIATRICS PEDILOC TIBIA PLATE 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 Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received01/27/2010
Decision Date 05/17/2010
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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