FDA 510(k) Application Details - K153398

Device Classification Name	Prosthesis, Elbow, Constrained, Cemented   More FDA Info for this Device
510(K) Number	K153398
Device Name	Prosthesis, Elbow, Constrained, Cemented
Applicant	BIOMET MANUFACTURING CORP. 56 BELL DRIVE WARSAW, IN 46580 US Other 510(k) Applications for this Company
Contact	PATRICIA SANDBORN BERES Other 510(k) Applications for this Contact
Regulation Number	888.3150   More FDA Info for this Regulation Number
Classification Product Code	JDC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/24/2015
Decision Date	02/03/2016
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