FDA 510(k) Application Details - K112030

Device Classification Name	Prosthesis, Elbow, Hemi-, Radial, Polymer   More FDA Info for this Device
510(K) Number	K112030
Device Name	Prosthesis, Elbow, Hemi-, Radial, Polymer
Applicant	SYNTHES USA, LLC 1301 Goshen Parkway West Chester, PA 19380 US Other 510(k) Applications for this Company
Contact	ANGELA F LASSANDRO Other 510(k) Applications for this Contact
Regulation Number	888.3170   More FDA Info for this Regulation Number
Classification Product Code	KWI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/15/2011
Decision Date	06/19/2012
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