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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
510(k) Number K152439
Device Name U2 Bipolar Implant and 22mm Femoral Head
Applicant
United Orthopedic Corporation
No 57, Park Ave. 2, Science Park
Hsinchu,  TW 300
Applicant Contact Karen Ho
Correspondent
United Orthopedic Corporation
No 57, Park Ave. 2, Science Park
Hsinchu,  TW 300
Correspondent Contact Karen Ho
Regulation Number888.3390
Classification Product Code
KWY  
Date Received08/27/2015
Decision Date 04/07/2016
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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