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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 K081407
Device Name ORTHOPEDIATRICS PEDIPLATES 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 Codes
HWC   OBT  
Date Received05/19/2008
Decision Date 07/22/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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