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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Threaded
510(k) Number K970713
Device Name COMPASS UNIVERSAL HINGE
Applicant
Smith & Nephew, Inc., Orthopaedic Div.
1450 Brooks Rd.
Memphis,  TN  38116
Applicant Contact JO ANN KUHNE
Correspondent
Smith & Nephew, Inc., Orthopaedic Div.
1450 Brooks Rd.
Memphis,  TN  38116
Correspondent Contact JO ANN KUHNE
Regulation Number888.3040
Classification Product Code
JDW  
Date Received02/27/1997
Decision Date 04/03/1997
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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