The following data is part of a premarket notification filed by 4web, Inc. with the FDA for Cervical Spinal Truss System-stand Alone (csts-sa).
| Device ID | K190870 |
| 510k Number | K190870 |
| Device Name: | Cervical Spinal Truss System-Stand Alone (CSTS-SA) |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | 4Web, Inc. 2801 Network Blvd. Suite 620 Frisco, TX 75034 |
| Contact | Jessee Hunt |
| Correspondent | Rich Jansen Silver Pine Consulting, LLC. 3851 Mossy Oak Drive Ft. Myers, FL 33905 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-03 |
| Decision Date | 2019-08-12 |