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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/ceramic/polymer, cemented or non-porous, uncemented
510(k) Number K122296
Device Name SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING
Original Applicant
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis,  TN  38116
Original Contact john connor
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWY   LWJ  
Date Received07/31/2012
Decision Date 08/28/2012
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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