Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K031901 |
Device Name |
PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT |
Applicant |
STELKAST COMPANY |
200 HIDDEN VALLEY RD. |
MCMURRAY,
PA
15317
|
|
Applicant Contact |
DONALD A STEVENS |
Correspondent |
STELKAST COMPANY |
200 HIDDEN VALLEY RD. |
MCMURRAY,
PA
15317
|
|
Correspondent Contact |
DONALD A STEVENS |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 06/20/2003 |
Decision Date | 10/10/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|