Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K151716 |
Device Name |
Cable-Ready Cable Grip System: Cable-Ready Bone Plate System |
Applicant |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46580
|
|
Applicant Contact |
Patrick McCullagh |
Correspondent |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46580
|
|
Correspondent Contact |
Dalene Binkley |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/25/2015 |
Decision Date | 01/28/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|