FDA 510(k) Application Details - K243248

Device Classification Name	More FDA Info for this Device
510(K) Number	K243248
Device Name	INHANCE INTACTÖ
Applicant	Depuy Ireland UC Loughbeg Ringaskiddy Ringaskiddy IE Other 510(k) Applications for this Company
Contact	Sanjay Shah Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/11/2024
Decision Date	12/23/2024
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