Device Classification Name |
intervertebral fusion device with integrated fixation, lumbar
|
510(k) Number |
K200002 |
Device Name |
Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device |
Applicant |
4Web, Inc. |
2801 Network Blvd., Suite 620 |
Frisco,
TX
75034
|
|
Applicant Contact |
Jessee Hunt |
Correspondent |
Silver Pine Consulting, LLC. |
3851 Mossy Oak Drive |
Ft. Myers,
FL
33905
|
|
Correspondent Contact |
Rich Jansen |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 01/02/2020 |
Decision Date | 05/29/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|