The following data is part of a premarket notification filed by Wenzel Spine, Inc. with the FDA for Varilift-lx Interbody Fusion System, Varilift-c Interbody Fusion System.
| Device ID | K180822 |
| 510k Number | K180822 |
| Device Name: | VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Wenzel Spine, Inc. 1130 Rutherford Lane, Suite 200 Austin, TX 78753 |
| Contact | Beckinam Nowatzke |
| Correspondent | Erik Emstad Wenzel Spine, Inc. 1130 Rutherford Lane, Suite 200 Austin, TX 78753 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-30 |
| Decision Date | 2019-01-28 |