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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Washer, Bolt Nut
510(k) Number K132733
FOIA Releasable 510(k) K132733
Device Name ORTHOHELIX SYNDESMOSIS FIXATION DEVICES
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
HTN  
Date Received09/03/2013
Decision Date 01/03/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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