Device Classification Name |
Intervertebral Fusion Device With Integrated Fixation, Cervical
|
510(k) Number |
K190870 |
Device Name |
Cervical Spinal Truss System-Stand Alone (CSTS-SA) |
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 | 04/03/2019 |
Decision Date | 08/12/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|