Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K091014 |
Device Name |
JOURNEY BCS KNEE SYSTEM |
Applicant |
SMITH & NEPHEW, INC. |
1450 BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Applicant Contact |
JASON SELLS |
Correspondent |
SMITH & NEPHEW, INC. |
1450 BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Correspondent Contact |
JASON SELLS |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 04/09/2009 |
Decision Date | 09/29/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|