FDA 510(k) Application Details - K120374

Device Classification Name	More FDA Info for this Device
510(K) Number	K120374
Device Name	SEVIIN REVERSE SHOULDER
Applicant	INGEN ORTHOPEDICS LLC 2650 US HIGHWAY 130 CRANBURY, NJ 08512 US Other 510(k) Applications for this Company
Contact	PERRY GEREMAKIS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/06/2012
Decision Date	07/09/2012
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