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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Elbow, Semi-Constrained, Cemented
510(k) Number K011567
Device Name TORNIER TOTAL ELBOW PROSTHESIS
Applicant
Tornier
Zirst-161, Rue Lavoisier
Montbonnot,  FR 38330
Applicant Contact IRENE GOSSET
Correspondent
Tornier
Zirst-161, Rue Lavoisier
Montbonnot,  FR 38330
Correspondent Contact IRENE GOSSET
Regulation Number888.3160
Classification Product Code
JDB  
Subsequent Product Code
JDC  
Date Received05/21/2001
Decision Date 06/19/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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