Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K201527 |
Device Name |
EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm) |
Applicant |
Smith & Nephew, Inc. |
7135 Goodlett Farms Parkway |
Cordova,
TN
38016
|
|
Applicant Contact |
Kayla Franklin |
Correspondent |
Smith & Nephew, Inc. |
7135 Goodlett Farms Parkway |
Cordova,
TN
38016
|
|
Correspondent Contact |
Kayla Franklin |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 06/08/2020 |
Decision Date | 07/22/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|