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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 K050848
Device Name TORNIER ELBOW PROSTHESIS
Applicant
Tornier
161 Rue Lavoisier
Monbonnot Saint Martin,  FR 38334
Applicant Contact Mireille Lemery
Correspondent
Tornier
161 Rue Lavoisier
Monbonnot Saint Martin,  FR 38334
Correspondent Contact Mireille Lemery
Regulation Number888.3160
Classification Product Code
JDB  
Subsequent Product Code
JDC  
Date Received04/04/2005
Decision Date 07/14/2005
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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