Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K150121 |
Device Name |
Zimmer Periarticular Plating 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 H MCKELVEY |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 01/20/2015 |
Decision Date | 02/23/2015 |
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
|
|
|