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FDA 510(k) Application Details - K090076
Device Classification Name
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
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510(K) Number
K090076
Device Name
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Applicant
TORNIER
161 RUE LAVOISIER
MONTBONNOT
SAINT-ISMIER CEDEX 38334 FR
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Contact
SEVERINE BONNETON
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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
01/12/2009
Decision Date
03/17/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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