Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K972690 |
Device Name |
ZIRCONIA CERAMIC FEMORAL HEAD |
Applicant |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Applicant Contact |
KAREN CAIN |
Correspondent |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Correspondent Contact |
KAREN CAIN |
Regulation Number | 888.3353
|
Classification Product Code |
|
Date Received | 07/17/1997 |
Decision Date | 10/15/1997 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|