FDA 510(k) Application Details - K190344

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented   More FDA Info for this Device
510(K) Number	K190344
Device Name	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Applicant	DePuy (Ireland) Loughbeg Ringaskiddy Co. Cork IE Other 510(k) Applications for this Company
Contact	Kathy Harris Other 510(k) Applications for this Contact
Regulation Number	888.3353   More FDA Info for this Regulation Number
Classification Product Code	LZO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/14/2019
Decision Date	11/01/2019
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