The following data is part of a premarket notification filed by 4-web Spine, Llc with the FDA for Alif Spinal Truss Interbody Fusion Device.
| Device ID | K083894 |
| 510k Number | K083894 |
| Device Name: | ALIF SPINAL TRUSS INTERBODY FUSION DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | 4-WEB SPINE, LLC 13540 GUILD AVENUE Apple Valley, MN 55124 |
| Contact | Richard Jansen |
| Correspondent | Richard Jansen 4-WEB SPINE, LLC 13540 GUILD AVENUE Apple Valley, MN 55124 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-29 |
| Decision Date | 2011-01-18 |
| Summary: | summary |