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FDA 510(k) Application Details - K232226
Device Classification Name
More FDA Info for this Device
510(K) Number
K232226
Device Name
ARROW Off-Centred Humeral Insert
Applicant
FH Industrie
6 rue Nobel, Zi De Kernevez
Quimper 29000 FR
Other 510(k) Applications for this Company
Contact
Naoual Rahimi
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
07/27/2023
Decision Date
08/29/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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