Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K141517 |
Device Name |
ZIMMER PLATES AND SCREWS (ZPS)-NON-STERILE PLATES |
Applicant |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Applicant Contact |
STEPHEN H MCKELVEY,MA, RAC |
Correspondent |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Correspondent Contact |
STEPHEN H MCKELVEY,MA, RAC |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 06/09/2014 |
Decision Date | 08/13/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|