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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 K132591
Device Name MAXLOCK EXTREME SYSTEM
Applicant
ORTHOHELIX SURGICAL DESIGNS, INC.
1065 MEDINA ROAD
SUITE 500
MEDINA,  OH  44256
Applicant Contact DEREK LEWIS
Correspondent
ORTHOHELIX SURGICAL DESIGNS, INC.
1065 MEDINA ROAD
SUITE 500
MEDINA,  OH  44256
Correspondent Contact DEREK LEWIS
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received08/19/2013
Decision Date 09/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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