FDA 510(k) Application Details - K140701

Device Classification Name	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented   More FDA Info for this Device
510(K) Number	K140701
Device Name	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Applicant	NOVOSOURCE INC 9001 Wesleyan Road, Suite 200 Indianapolis, IN 46268 US Other 510(k) Applications for this Company
Contact	ALLISON SCOTT, RAC Other 510(k) Applications for this Contact
Regulation Number	888.3358   More FDA Info for this Regulation Number
Classification Product Code	OQG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/20/2014
Decision Date	06/27/2014
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