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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
Original Applicant
UNITED ORTHOPEDIC CORP.
57 park ave. 2, science park
hsinchu,  TW 300
Original 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
Recalls CDRH Recalls
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