Device Classification Name |
Cerclage, Fixation
|
510(k) Number |
K151848 |
Device Name |
Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle 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 | 888.3010
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/07/2015 |
Decision Date | 01/15/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|