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