Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K953714 |
Device Name |
ZIMMER RECONSTRUCTION SYSTEM SYMPHYSEAL BONE PLATE |
Applicant |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Applicant Contact |
LYNETTE WHITAKER |
Correspondent |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Correspondent Contact |
LYNETTE WHITAKER |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 08/09/1995 |
Decision Date | 11/20/1995 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|