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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 K123012
Device Name SMITH & NEPHEW SMF HIP STEM
Applicant
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis,  TN  38116
Contact natalie p williams
Regulation Number888.3358
Classification Product Code
LPH  
Date Received09/28/2012
Decision Date 10/24/2012
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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