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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 K121437
Device Name MINI MAXLOCK EXTREME PLATING SYSTEM
Applicant
Orthohelix Surgical Designs, Inc.
1065 Medina Rd., Suite 500
Medina,  OH  44256
Applicant Contact DEREK LEWIS
Correspondent
Orthohelix Surgical Designs, Inc.
1065 Medina Rd., Suite 500
Medina,  OH  44256
Correspondent Contact DEREK LEWIS
Regulation Number888.3030
Classification Product Code
HRS  
Date Received05/15/2012
Decision Date 06/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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