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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerclage, Fixation
510(k) Number K151346
Device Name Frontier Medical Devices Posterior Cable Screw System
Applicant
Frontier Medical Devices, Inc.
512 Fourth St.
Gwinn,  MI  49841
Applicant Contact BETHANY BYMAN
Correspondent
Frontier Medical Devices, Inc.
512 Fourth St.
Gwinn,  MI  49841
Correspondent Contact BETHANY BYMAN
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received05/20/2015
Decision Date 08/20/2015
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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