Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K181533 |
Device Name |
EVOS Wrist Fracture Plating System |
Applicant |
Smith & Nephew, Inc. |
1450 Brooks Road |
Memphis,
TN
38116
|
|
Applicant Contact |
Bryan Cowell |
Correspondent |
Smith & Nephew, Inc. |
1450 Brooks Road |
Memphis,
TN
38116
|
|
Correspondent Contact |
Bryan Cowell |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 06/11/2018 |
Decision Date | 08/09/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|