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FDA 510(k) Application Details - K161789
Device Classification Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
More FDA Info for this Device
510(K) Number
K161789
Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Applicant
TORNIER SAS
161 RUE LAVOISIER
MONTBONNOT SAINT-MARTIN 38330 FR
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Contact
AYMEN AZAIEZ
Other 510(k) Applications for this Contact
Regulation Number
888.3660
More FDA Info for this Regulation Number
Classification Product Code
KWS
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More FDA Info for this Product Code
Date Received
06/29/2016
Decision Date
12/27/2016
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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