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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 K970748
Device Name TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM
Applicant
Smith & Nephew, Inc., Orthopaedic Div.
1450 Brooks Rd.
Memphis,  TN  38116
Applicant Contact JOANNE KUHNE
Correspondent
Smith & Nephew, Inc., Orthopaedic Div.
1450 Brooks Rd.
Memphis,  TN  38116
Correspondent Contact JOANNE KUHNE
Regulation Number888.3030
Classification Product Code
KTT  
Date Received03/03/1997
Decision Date 05/09/1997
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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