Device Classification Name |
Pin, Fixation, Threaded
|
510(k) Number |
K213874 |
Device Name |
MAVERICK External Fixation System |
Applicant |
Smith & Nephew, Inc. |
7135 Goodlett Farms Parkway |
Cordova,
TN
38016
|
|
Applicant Contact |
Brad Sheals |
Correspondent |
Smith & Nephew, Inc. |
7135 Goodlett Farms Parkway |
Cordova,
TN
38016
|
|
Correspondent Contact |
Brad Sheals |
Regulation Number | 888.3040
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/13/2021 |
Decision Date | 02/11/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|