Device Classification Name |
Rod, Fixation, Intramedullary And Accessories
|
510(k) Number |
K161264 |
Device Name |
TRIGEN Low Profile Bone Screws |
Applicant |
SMITH & NEPHEW, INC. |
1450 E. BROOKS ROAD |
MEMPHIS,
TN
38116
|
|
Applicant Contact |
ALLISON CHAN |
Correspondent |
SMITH & NEPHEW, INC. |
1450 E. BROOKS ROAD |
MEMPHIS,
TN
38116
|
|
Correspondent Contact |
ALLISON CHAN |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 05/05/2016 |
Decision Date | 11/23/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|