Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K980276 |
Device Name |
STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM |
Applicant |
STELKAST COMPANY |
800 VINIAL ST. #210 |
PITTSBURGH,
PA
15212
|
|
Applicant Contact |
DONALD A STEVENS |
Correspondent |
STELKAST COMPANY |
800 VINIAL ST. #210 |
PITTSBURGH,
PA
15212
|
|
Correspondent Contact |
DONALD A STEVENS |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 01/26/1998 |
Decision Date | 04/24/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|