Device Classification Name |
Rod, Fixation, Intramedullary And Accessories
|
510(k) Number |
K043270 |
Device Name |
SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 02.02631, 02.02651, 02.02652 SERIES |
Applicant |
ZIMMER GMBH |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Applicant Contact |
LAURA D WILLIAMS |
Correspondent |
ZIMMER GMBH |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Correspondent Contact |
LAURA D WILLIAMS |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 11/26/2004 |
Decision Date | 01/31/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|