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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, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K094013
Device Name HLS KNEETEC SYSTEM
Applicant
Tornier
161 Rue Lavoisier
Monbonnot Saint Martin,  FR 38334
Applicant Contact SEVERINE BONNETON
Correspondent
Tornier
161 Rue Lavoisier
Monbonnot Saint Martin,  FR 38334
Correspondent Contact SEVERINE BONNETON
Regulation Number888.3560
Classification Product Code
JWH  
Date Received12/29/2009
Decision Date 05/05/2011
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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