The following data is part of a premarket notification filed by 4web Medical, Inc. with the FDA for Lateral Spine Truss System (lsts) Interbody Fusion Device.
| Device ID | K211388 |
| 510k Number | K211388 |
| Device Name: | Lateral Spine Truss System (LSTS) Interbody Fusion Device |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | 4WEB Medical, Inc. 2801 Network Blvd., Suite 620 Frisco, TX 75034 |
| Contact | Lewis Harrison |
| Correspondent | Richard Jansen Silver Pine Consulting 3851 Mossy Oak Drive Fort Myers, FL 33905 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-05 |
| Decision Date | 2021-08-05 |