Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K191516 |
Device Name |
Ali Interbody Fusion System |
Applicant |
Raed M. Ali, MD., Inc. |
6 Starcatcher |
Newport Coast,
CA
92657
|
|
Applicant Contact |
Raed Ali |
Correspondent |
TranS1 |
3804 Park Avenue |
Wilmington,
NC
28403
|
|
Correspondent Contact |
Kristen Allen |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 06/07/2019 |
Decision Date | 09/12/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|