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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 K003237
Device Name U2 HIP STEM, TI POROUS COATED
Applicant
United Orthopedic Corp.
# 57, Park Ave. 2, Science Park
Hsinchu,  TW 300
Applicant Contact MELLEN LIU
Correspondent
United Orthopedic Corp.
# 57, Park Ave. 2, Science Park
Hsinchu,  TW 300
Correspondent Contact MELLEN LIU
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
MEH  
Date Received10/17/2000
Decision Date 01/10/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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