Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K904205 |
Device Name |
AMK MODULAR TIBIAL WEDGE SYSTEM |
Applicant |
DEPUY, INC. |
P.O. BOX 988 |
WARSAW,
IN
46581 -0988
|
|
Applicant Contact |
DAVID A KOTKOVETZ |
Correspondent |
DEPUY, INC. |
P.O. BOX 988 |
WARSAW,
IN
46581 -0988
|
|
Correspondent Contact |
DAVID A KOTKOVETZ |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 09/12/1990 |
Decision Date | 10/22/1990 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|