The following data is part of a premarket notification filed by 4web, Inc. with the FDA for Lateral Spine Truss System.
| Device ID | K153436 |
| 510k Number | K153436 |
| Device Name: | LATERAL Spine Truss System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | 4Web, Inc. 6170 Research Rd., Suite 219 Frisco, TX 75033 |
| Contact | Jessee Hunt |
| Correspondent | Rich Jansen Silver Pine Consulting, LLC. 11821 Bramble Cove Drive Ft. Myers, FL 33905 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-27 |
| Decision Date | 2016-06-06 |
| Summary: | summary |