Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K955884 |
Device Name |
COORDINATE REVISION KNEE SYSTEM |
Applicant |
DEPUY, INC. |
700 ORTHOPAEDIC DR. |
WARSAW,
IN
46581 -0988
|
|
Applicant Contact |
CHERYL HASTINGS |
Correspondent |
DEPUY, INC. |
700 ORTHOPAEDIC DR. |
WARSAW,
IN
46581 -0988
|
|
Correspondent Contact |
CHERYL HASTINGS |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 12/28/1995 |
Decision Date | 03/13/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|