Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K123055 |
Device Name |
SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION |
Applicant |
SMITH & NEPHEW, INC. |
7135 Goodlett Farms Parkway |
Cordova,
TN
38016
|
|
Applicant Contact |
Bradley Heil |
Correspondent |
SMITH & NEPHEW, INC. |
7135 Goodlett Farms Parkway |
Cordova,
TN
38016
|
|
Correspondent Contact |
Bradley Heil |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/01/2012 |
Decision Date | 01/25/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|