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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K954712
Device Name INTRAMEDULLARY HIP SCREW (MODIFICATION)
Applicant
Smith & Nephew Richards, Inc.
1450 E. Brooks Rd.
Memphis,  TN  38116
Applicant Contact MARC A WHEETLEY
Correspondent
Smith & Nephew Richards, Inc.
1450 E. Brooks Rd.
Memphis,  TN  38116
Correspondent Contact MARC A WHEETLEY
Regulation Number888.3030
Classification Product Code
KTT  
Date Received08/16/1995
Decision Date 10/31/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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