FDA 510(k) Application Details - K132735

Device Classification Name	Prosthesis, Elbow, Hemi-, Radial, Polymer   More FDA Info for this Device
510(K) Number	K132735
Device Name	Prosthesis, Elbow, Hemi-, Radial, Polymer
Applicant	IMDS (INNOVATIVE MEDICAL DEVICE SYSTEMS) - LEIS ME 2710 DISCOVERY DRIVE, STE 600 CO-INNOVATION DIVISION ORLANDO, FL 32826 US Other 510(k) Applications for this Company
Contact	ANDREW RYNEARSON 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	09/03/2013
Decision Date	01/07/2014
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