Device Classification Name |
appliance, fixation, nail/blade/plate combination, multiple component
|
510(k) Number |
K042761 |
Device Name |
WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES |
Applicant |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Applicant Contact |
NOAH BARTSCH |
Correspondent |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Correspondent Contact |
NOAH BARTSCH |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 10/05/2004 |
Decision Date | 11/17/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|