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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
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