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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(k) Number K120262
Device Name HLS UNI EVOLUTION & U-KNEETEC
Applicant
Tornier, Inc.
161, Rue Lavoisier
Saint Ismier Cedex
Montbonnot,  FR 38334
Applicant Contact STEPHANIE BERNARD
Correspondent
Tornier, Inc.
161, Rue Lavoisier
Saint Ismier Cedex
Montbonnot,  FR 38334
Correspondent Contact STEPHANIE BERNARD
Regulation Number888.3520
Classification Product Code
HSX  
Date Received01/27/2012
Decision Date 07/25/2012
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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