Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K122883 |
Device Name |
EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM |
Applicant |
STELKAST COMPANY |
200 HIDDEN VALLEY RD. |
MCMURRAY,
PA
15317
|
|
Applicant Contact |
DAVID STUMPO |
Correspondent |
STELKAST COMPANY |
200 HIDDEN VALLEY RD. |
MCMURRAY,
PA
15317
|
|
Correspondent Contact |
DAVID STUMPO |
Regulation Number | 888.3560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/20/2012 |
Decision Date | 08/05/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|