FDA 510(k) Application Details - K112802

Device Classification Name	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented   More FDA Info for this Device
510(K) Number	K112802
Device Name	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Applicant	PIPELINE ORTHOPEDICS 901 KING STREET, SUITE 200 ALEXANDRIA, VA 22314 US Other 510(k) Applications for this Company
Contact	TERRY POWELL 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	09/27/2011
Decision Date	03/09/2012
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