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FDA 510(k) Application Details - K163397
Device Classification Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
More FDA Info for this Device
510(K) Number
K163397
Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Applicant
Limacorporate S.p.A.
via Nazionale 52
Villanova di San Daniele 33038 IT
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Contact
Michela Zanotto
Other 510(k) Applications for this Contact
Regulation Number
888.3670
More FDA Info for this Regulation Number
Classification Product Code
MBF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/05/2016
Decision Date
06/29/2017
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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