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FDA 510(k) Application Details - K212800
Device Classification Name
More FDA Info for this Device
510(K) Number
K212800
Device Name
PRIMA Humeral System and SMR Glenosphere ╪42
Applicant
LimaCorporate S.p.A.
Via Nazionale 52
Villanova di San Daniele del friuli 33038 IT
Other 510(k) Applications for this Company
Contact
Antonia Trevisan
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
09/02/2021
Decision Date
02/25/2022
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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