Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K021908 |
Device Name |
PROVEN MODULAR POSTERIOR STABILIZED FEMORAL |
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 | 06/10/2002 |
Decision Date | 07/09/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|