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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 K130533
Device Name SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS
Applicant
Tornier SAS
161 RUE LAVOISIER
MONTBONNOT SAINT MARTIN,  FR 38330
Applicant Contact SEVERINE BONNETON
Correspondent
Tornier SAS
161 RUE LAVOISIER
MONTBONNOT SAINT MARTIN,  FR 38330
Correspondent Contact SEVERINE BONNETON
Regulation Number888.3110
Classification Product Code
HSN  
Subsequent Product Codes
JDB   KWI  
Date Received03/01/2013
Decision Date 05/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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