FDA 510(k) Application Details - K063652

Device Classification Name	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented   More FDA Info for this Device
510(K) Number	K063652
Device Name	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Applicant	DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE WARSAW, IN 46581-0988 US Other 510(k) Applications for this Company
Contact	REBECCA LENNARD Other 510(k) Applications for this Contact
Regulation Number	888.3670   More FDA Info for this Regulation Number
Classification Product Code	MBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/08/2006
Decision Date	02/01/2007
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