Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K954684 |
Device Name |
DEPUY ANATOMIC MODULAR KNEE (AMK) CONGRUENCY POSTERIOR STABILIZED TIBIAL INSERT |
Applicant |
DEPUY, INC. |
P.O. BOX 988 |
700 ORTHOPAEDIC DRIVE |
WARSAW,
IN
46581 -0988
|
|
Applicant Contact |
DAVID A KOTKOVETZ |
Correspondent |
DEPUY, INC. |
P.O. BOX 988 |
700 ORTHOPAEDIC DRIVE |
WARSAW,
IN
46581 -0988
|
|
Correspondent Contact |
DAVID A KOTKOVETZ |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 10/11/1995 |
Decision Date | 01/26/1996 |
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
|
|
|