Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K032215 |
Device Name |
VKS/TC-PLUS REVISION KNEE |
Applicant |
PLUS ORTHOPEDICS |
1001 OAKWOOD BLVD. |
ROUND ROCK,
TX
78681 -2700
|
|
Applicant Contact |
J.D. WEBB |
Correspondent |
PLUS ORTHOPEDICS |
1001 OAKWOOD BLVD. |
ROUND ROCK,
TX
78681 -2700
|
|
Correspondent Contact |
J.D. WEBB |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 07/21/2003 |
Decision Date | 08/08/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|