FDA 510(k) Application Details - K173499

Device Classification Name	Prosthesis, Hip, Femoral Component, Cemented, Metal   More FDA Info for this Device
510(K) Number	K173499
Device Name	Prosthesis, Hip, Femoral Component, Cemented, Metal
Applicant	Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 US Other 510(k) Applications for this Company
Contact	Kirsten Lehmuller Other 510(k) Applications for this Contact
Regulation Number	888.3360   More FDA Info for this Regulation Number
Classification Product Code	JDG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/2017
Decision Date	03/19/2018
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