Device Classification Name |
prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
|
510(k) Number |
K071790 |
Device Name |
GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, 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 | 888.3565
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/02/2007 |
Decision Date | 08/17/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|