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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 K060544
Device Name SALTO TALARIS TOTAL ANKLE PROSTHESIS
Applicant
TORNIER
RUE DOYEN GOSSE
ST. ISMIER,  FR 38330
Applicant Contact MIREILLE EMERY
Correspondent
TORNIER
RUE DOYEN GOSSE
ST. ISMIER,  FR 38330
Correspondent Contact MIREILLE EMERY
Regulation Number888.3110
Classification Product Code
HSN  
Date Received03/01/2006
Decision Date 11/13/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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