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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 K120211
Device Name SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING
Applicant
SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Applicant Contact JOHN CONNOR
Correspondent
SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Correspondent Contact JOHN CONNOR
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWY   LWJ  
Date Received01/24/2012
Decision Date 07/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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