Device Classification Name |
intervertebral body graft containment device
|
De Novo Number |
DEN200010 |
Device Name |
Spineology Interbody Fusion System |
Requester |
spineology, inc. |
7800 3rd street north, suite 600 |
saint paul,
MN
55128
|
|
Contact |
andrew adams |
|
Regulation Number | 888.3085
|
Classification Product Code |
|
Date Received | 02/19/2020 |
Decision Date | 09/18/2020 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Orthopedic
|
Review Advisory Committee |
Orthopedic
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|