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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 K121777
Device Name U2 ACETABULAR CUP, PLASMA SPRAY
Applicant
United Orthopedic Corp.
# 57, Park Ave. 2, Science Park
Hsinchu,  TW 300
Applicant Contact FANG-YUAN HO
Correspondent
United Orthopedic Corp.
# 57, Park Ave. 2, Science Park
Hsinchu,  TW 300
Correspondent Contact FANG-YUAN HO
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
MEH  
Date Received06/18/2012
Decision Date 07/18/2012
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
Recalls CDRH Recalls
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