Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K024161 |
Device Name |
NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS |
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 | 12/17/2002 |
Decision Date | 01/15/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|