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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, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(k) Number K162957
Device Name U2 Femoral Head
Applicant
United Orthopedic Corporation
No 57, Park Ave. 2, Science Park
Hsinchu,  TW 300
Applicant Contact GIMPEL CHIEN
Correspondent
United Orthopedic Corporation
No 57, Park Ave. 2, Science Park
Hsinchu,  TW 300
Correspondent Contact GIMPEL CHIEN
Regulation Number888.3358
Classification Product Code
LPH  
Date Received10/24/2016
Decision Date 07/17/2017
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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