FDA 510(k) Application Details - K182678

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented   More FDA Info for this Device
510(K) Number	K182678
Device Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Applicant	Zimmer, Inc PO Box 708 Warsaw, IN 46581-0708 US Other 510(k) Applications for this Company
Contact	Caleb Barylski Other 510(k) Applications for this Contact
Regulation Number	888.3358   More FDA Info for this Regulation Number
Classification Product Code	LPH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2018
Decision Date	05/31/2019
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