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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 K141301
Device Name MAXLOCK EXTREME ELBOW FRACTURE SYSTEM
Applicant
ORTHOHELIX SURGICAL DESIGNS, INC.
1065 Medina Rd.
SUITE 500
Medina,  OH  44256
Applicant Contact BRIAN HOCKETT
Correspondent
ORTHOHELIX SURGICAL DESIGNS, INC.
1065 Medina Rd.
SUITE 500
Medina,  OH  44256
Correspondent Contact BRIAN HOCKETT
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received05/19/2014
Decision Date 07/11/2014
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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