Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K162078 |
Device Name |
EVOS Small Fragment Plating System |
Applicant |
SMITH & NEPHEW, INC. |
1450 BROOKS ROAD |
MEMPHIS,
TN
38119
|
|
Applicant Contact |
SAMANTHA STAUBACH |
Correspondent |
SMITH & NEPHEW, INC. |
1450 BROOKS ROAD |
MEMPHIS,
TN
38119
|
|
Correspondent Contact |
SAMANTHA STAUBACH |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/27/2016 |
Decision Date | 11/18/2016 |
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
|
|
|