FDA 510(k) Application Details - K240639

Device Classification Name	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K240639
Device Name	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Applicant	Depuy Ireland UC Loughbeg Ringaskiddy Ringaskiddy Cork GB Other 510(k) Applications for this Company
Contact	Jennifer Hill Other 510(k) Applications for this Contact
Regulation Number	888.3310   More FDA Info for this Regulation Number
Classification Product Code	KWZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/06/2024
Decision Date	04/04/2024
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