FDA 510(k) Application Details - K191414

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented   More FDA Info for this Device
510(K) Number	K191414
Device Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Applicant	Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 US Other 510(k) Applications for this Company
Contact	Denise Daugert Other 510(k) Applications for this Contact
Regulation Number	888.3350   More FDA Info for this Regulation Number
Classification Product Code	JDI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/28/2019
Decision Date	08/28/2019
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