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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
510(k) Number K090076
Device Name SALTO TALARIS TOTAL ANKLE PROSTHESIS
Applicant
Tornier
161 Rue Lavoisier
Montbonnot
Saint-Ismier Cedex,  FR 38334
Applicant Contact SEVERINE BONNETON
Correspondent
Tornier
161 Rue Lavoisier
Montbonnot
Saint-Ismier Cedex,  FR 38334
Correspondent Contact SEVERINE BONNETON
Regulation Number888.3110
Classification Product Code
HSN  
Date Received01/12/2009
Decision Date 03/17/2009
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
Recalls CDRH Recalls
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