Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K040630 |
Device Name |
TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ |
Applicant |
IMPLEX CORP. |
80 COMMERCE DR. |
ALLENDALE,
NJ
07401 -1600
|
|
Applicant Contact |
MARCI HALEVI |
Correspondent |
IMPLEX CORP. |
80 COMMERCE DR. |
ALLENDALE,
NJ
07401 -1600
|
|
Correspondent Contact |
MARCI HALEVI |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 03/10/2004 |
Decision Date | 09/30/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|