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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, 
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 (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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