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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K171211
Device Name OIC External Fixation System
Applicant
Orthopaedic Implant Company
770 Smithridge Dr.
#400
Reno,  NV  89502
Applicant Contact Douglas Fulton
Correspondent
Orthopaedic Implant Company
770 Smithridge Dr.
#400
Reno,  NV  89502
Correspondent Contact Douglas Fulton
Regulation Number888.3030
Classification Product Code
KTT  
Date Received04/25/2017
Decision Date 09/27/2017
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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