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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Fixation, Proximal Femoral, Implant
510(k) Number K152686
Device Name CONQUEST FN
Applicant
Smith & Nephew
1450 E. Brooks Rd.
Memphis,  TN  38116
Applicant Contact Bradley Heil
Correspondent
Smith & Nephew
1450 E. Brooks Rd.
Memphis,  TN  38116
Correspondent Contact Bradley Heil
Regulation Number888.3030
Classification Product Code
JDO  
Subsequent Product Code
KTT  
Date Received09/18/2015
Decision Date 03/17/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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