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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 K993289
Device Name SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM
Applicant
Smith & Nephew, Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Applicant Contact JANET JOHNSON GREEN
Correspondent
Smith & Nephew, Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Correspondent Contact JANET JOHNSON GREEN
Regulation Number888.3030
Classification Product Code
KTT  
Date Received10/01/1999
Decision Date 12/20/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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