Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
|
510(k) Number |
K042337 |
Device Name |
ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING |
Applicant |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Applicant Contact |
DALENE BINKLEY |
Correspondent |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Correspondent Contact |
DALENE BINKLEY |
Regulation Number | 888.3358
|
Classification Product Code |
|
Date Received | 08/30/2004 |
Decision Date | 11/04/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|