The following data is part of a premarket notification filed by 4web, Inc. with the FDA for Posterior Spine Truss System (psts) Interbody Fusion Device.
| Device ID | K171351 |
| 510k Number | K171351 |
| Device Name: | Posterior Spine Truss System (PSTS) Interbody Fusion Device |
| 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. 3851 Mossy Oak 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 | 2017-05-09 |
| Decision Date | 2017-09-08 |
| Summary: | summary |