FDA 510(k) Application Details - K112897

Device Classification Name	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented   More FDA Info for this Device
510(K) Number	K112897
Device Name	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Applicant	RENOVIS SURGICAL TECHNOLOGIES, LLC 825 NICOLLET MALL STE 1820 MINNEAPOLIS, MN 55402 US Other 510(k) Applications for this Company
Contact	DAVID A TEICHER 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	10/03/2011
Decision Date	06/13/2012
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