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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 K132435
Device Name SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS
Applicant
SMITH & NEPHEW, INC.
7135 Goodlett Farms Parkway
Cordova,  TN  38016
Applicant Contact MEGAN FESSENDEN
Correspondent
SMITH & NEPHEW, INC.
7135 Goodlett Farms Parkway
Cordova,  TN  38016
Correspondent Contact MEGAN FESSENDEN
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDI   KWY   LPH   LWJ   MBL  
MEH  
Date Received08/05/2013
Decision Date 10/22/2013
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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