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 |
|