Device Classification Name |
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
More FDA Info for this Device |
510(K) Number |
K150028 |
Device Name |
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
Applicant |
ZIMMER, INC.
P.O. BOX 708
WARSAW, IN 46581-0708 US
Other 510(k) Applications for this Company
|
Contact |
KEITH J. PROCTOR
Other 510(k) Applications for this Contact |
Regulation Number |
888.3510
More FDA Info for this Regulation Number |
Classification Product Code |
KRO
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
01/07/2015 |
Decision Date |
02/06/2015 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
OR - Orthopedic |
Review Advisory Committee |
OR - Orthopedic |
Statement / Summary / Purged Status |
Summary |
Type |
Special |
Reviewed By Third Party |
N |
Expedited Review |
|