Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K201918 |
Device Name |
EVOS Large Fragment Plating System |
Applicant |
Smith & Nephew, Inc. |
1450 E Brooks Rd |
Memphis,
TN
38116
|
|
Applicant Contact |
Thomas Fearnley |
Correspondent |
Smith & Nephew, Inc. |
1450 E Brooks Rd |
Memphis,
TN
38116
|
|
Correspondent Contact |
Thomas Fearnley |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/10/2020 |
Decision Date | 11/16/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|