Device Classification Name |
rod, fixation, intramedullary and accessories
|
510(k) Number |
K120715 |
Device Name |
ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT |
Applicant |
ZIMMER GMBH |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Applicant Contact |
STEPHEN H MCKELVEY |
Correspondent |
ZIMMER GMBH |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Correspondent Contact |
STEPHEN H MCKELVEY |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 03/08/2012 |
Decision Date | 08/10/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|