FDA 510(k) Application Details - K212933

Device Classification Name	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented   More FDA Info for this Device
510(K) Number	K212933
Device Name	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
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	888.3670   More FDA Info for this Regulation Number
Classification Product Code	MBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/15/2021
Decision Date	06/08/2022
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