FDA 510(k) Application Details - K223211

Device Classification Name	More FDA Info for this Device
510(K) Number	K223211
Device Name	INHANCETM Shoulder System û Humeral Stems and Stemless
Applicant	Depuy Ireland UC Loughbeg Ringaskiddy IE Other 510(k) Applications for this Company
Contact	Yayoi Fujimaki 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	10/17/2022
Decision Date	12/02/2022
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