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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 K131093
Device Name ORTHOLOC(R) 3DI ANKLE PLATING SYSTEM
Applicant
Wrightmedicaltechnologyinc
5677 Airline Rd.
Arlington,  TN  38002
Applicant Contact RYAN BORMANN
Correspondent
Wrightmedicaltechnologyinc
5677 Airline Rd.
Arlington,  TN  38002
Correspondent Contact RYAN BORMANN
Regulation Number888.3030
Classification Product Code
HRS  
Date Received04/18/2013
Decision Date 05/21/2013
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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