FDA 510(k) Application Details - K131277

Device Classification Name	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented   More FDA Info for this Device
510(K) Number	K131277
Device Name	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Applicant	INGEN ORTHOPEDICS LLC 2650 US HIGHWAY 130 CRANBURY, NJ 08512 US Other 510(k) Applications for this Company
Contact	PERRY A GEREMAKIS Other 510(k) Applications for this Contact
Regulation Number	888.3660   More FDA Info for this Regulation Number
Classification Product Code	KWS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/06/2013
Decision Date	08/28/2013
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