The following data is part of a premarket notification filed by 4web, Inc. with the FDA for Lumbar Spine Truss System Plating Solution (lsts-ps).
| Device ID | K203065 |
| 510k Number | K203065 |
| Device Name: | Lumbar Spine Truss System Plating Solution (LSTS-PS) |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| 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 | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-09 |
| Decision Date | 2021-03-10 |