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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 K111086
Device Name ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM
Applicant
ORTHOPEDIATRICS, CORP
2850 FRONTIER DRIVE
WARSAW,  IN  46582
Applicant Contact MARK FOX
Correspondent
ORTHOPEDIATRICS, CORP
2850 FRONTIER DRIVE
WARSAW,  IN  46582
Correspondent Contact MARK FOX
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received04/19/2011
Decision Date 06/17/2011
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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