FDA 510(k) Application Details - K093803

Device Classification Name	More FDA Info for this Device
510(K) Number	K093803
Device Name	BIO-MODULAR REVERSE SHOLDER
Applicant	BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE WARSAW, IN 46582 US Other 510(k) Applications for this Company
Contact	PATRICIA SANDBORN BERES 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	12/11/2009
Decision Date	10/19/2010
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