Device Classification Name |
Rod, Fixation, Intramedullary And Accessories
|
510(k) Number |
K143321 |
Device Name |
ITST Intertrochanteric/Subtrochanteric Fixation System |
Applicant |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Applicant Contact |
PATRICK MCCULLAGH |
Correspondent |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Correspondent Contact |
Stephen McKelvey |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 11/19/2014 |
Decision Date | 05/29/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|