Device Classification Name |
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
|
510(k) Number |
K081351 |
Device Name |
MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT |
Applicant |
SMITH & NEPHEW, INC. |
1450 E BROOKS ROAD |
MEMPHIS,
TN
38116
|
|
Applicant Contact |
NICHOLAS B TABRIZI |
Correspondent |
SMITH & NEPHEW, INC. |
1450 E BROOKS ROAD |
MEMPHIS,
TN
38116
|
|
Correspondent Contact |
NICHOLAS B TABRIZI |
Regulation Number | 888.3520
|
Classification Product Code |
|
Date Received | 05/14/2008 |
Decision Date | 07/24/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|