FDA 510(k) Application Details - K152919

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented   More FDA Info for this Device
510(K) Number	K152919
Device Name	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Applicant	OMNILIFE SCIENCE INC. 50 O'CONNELL WAY SUITE 10 EAST TAUNTON, MA 02718 US Other 510(k) Applications for this Company
Contact	Vani Sindwani 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	10/02/2015
Decision Date	03/10/2016
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