The following data is part of a premarket notification filed by 4web, Inc. with the FDA for Cervical Spinal Truss System (csts) Interbody Fusion Device.
| Device ID | K173159 |
| 510k Number | K173159 |
| Device Name: | Cervical Spinal Truss System (CSTS) Interbody Fusion Device |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | 4Web, Inc. 2801 Network Blvd.,Suite 620 Frisco, TX 75034 |
| Contact | Jessee Hunt |
| Correspondent | Rich Jansen Silver Pine Consulting 11821 Bramble Cove Drive Ft. Myers, FL 33905 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2018-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812998033607 | K173159 | 000 |
| 00812998033591 | K173159 | 000 |
| 00812998033584 | K173159 | 000 |
| 00812998033577 | K173159 | 000 |