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FDA 510(k) Application Details - K161120
Device Classification Name
More FDA Info for this Device
510(K) Number
K161120
Device Name
SMR TT Metal Back Glenoid, Bone Graft instruments
Applicant
LIMACORPORATE S.P.A.
VIA NAZIONALE 52
VILLANOVA DI SAN DANIELE 33038 IT
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Contact
Emanuele Buttazzoni
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PHX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/21/2016
Decision Date
02/21/2017
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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