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FDA 510(k) Application Details - K202024
Device Classification Name
More FDA Info for this Device
510(K) Number
K202024
Device Name
ARROW Short Stem Humeral System
Applicant
FH Industrie
6 rue Nobel, Zi De Kernevez
Quimper 29000 FR
Other 510(k) Applications for this Company
Contact
Patricia Donnard
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
07/22/2020
Decision Date
11/30/2021
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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