The following data is part of a premarket notification filed by 4-web, Inc. with the FDA for 4-web Alif Spinal Truss System (sts).
| Device ID | K112316 |
| 510k Number | K112316 |
| Device Name: | 4-WEB ALIF SPINAL TRUSS SYSTEM (STS) |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | 4-WEB, INC. 13540 GUILD AVE. Apple Valley, MN 55124 |
| Contact | Rich Jansen, Pharm. D. |
| Correspondent | Rich Jansen, Pharm. D. 4-WEB, INC. 13540 GUILD AVE. Apple Valley, MN 55124 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-11 |
| Decision Date | 2011-12-14 |
| Summary: | summary |