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FDA 510(k) Application Details - K060544
Device Classification Name
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
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510(K) Number
K060544
Device Name
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Applicant
TORNIER
RUE DOYEN GOSSE
ST. ISMIER 38330 FR
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Contact
MIREILLE EMERY
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Regulation Number
888.3110
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Classification Product Code
HSN
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More FDA Info for this Product Code
Date Received
03/01/2006
Decision Date
11/13/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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