VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System
FDA 510(k) K180822 · Wenzel Spine, Inc.
510(k) numberK180822
Submission
- Device name
- VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System
- Applicant
- Wenzel Spine, Inc.
Austin, TX, US - Received
- March 30, 2018
- Decision date
- January 28, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Other 510(k)s with product code MAX
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|---|---|---|---|
| K261049 | Scala® TLMAX · Traditional | Spineart SA | 08/20/2026SE |
| K261430 | TruLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 07/28/2026SE |
| K253011 | Catalyft PL Expandable Interbody SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/17/2026SE |
| K261020 | Symmetrix L Spinal SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/14/2026SE |
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional | SeaSpine Orthopedics Corporation | 07/01/2026SE |
| K253151 | Fule Interbody Fusion Cage SystemMAX · Traditional | Beijing Fule Science & Technology Development… | 06/15/2026SE |
| K261159 | Exceed® Biplanar Expandable Interbody SystemMAX · Traditional | Spine Wave, Inc. | 05/29/2026SE |
| K253894 | BMD Titanium Spinal Fusion SystemMAX · Traditional | Global Biomedica s.r.o. | 05/28/2026SE |
| K260506 | Ventana® P/T Lumbar Interbody SystemMAX · Traditional | Spinal Elements, Inc. | 05/15/2026SE |
| K260837 | VersaLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 05/12/2026SE |
More from Life Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K262595 | VariLift-C Cervical Interbody Fusion SystemODP · Special | 08/26/2026SE |
| K250247 | panaSIa SI Fusion SystemOUR · Traditional | 07/09/2025SE |
| K231076 | VariLift®-C Interbody Fusion SystemODP · Traditional | 09/27/2023SE |
| K231807 | primaLOK SP Interspinous Fusion SystemPEK · Traditional | 08/15/2023SE |
| K151900 | VariLift-L Interbody Fusion DeviceMAX · Traditional | 12/11/2015SE |
| K131296 | Varilift-L Interbody Fusion DeviceMAX · Traditional | 09/03/2013SE |
| K120603 | Varilift -CODP · Traditional | 01/29/2013SE |
| K111123 | Varilift Cervical Interbody Fusion SystemODP · Traditional | 12/08/2011SE |
| K100820 | Wenzel Spine Varilift Interbody Fusion SystemMAX · Traditional | 08/05/2010SE |
Questions and answers
When was VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System cleared by the FDA?
VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System (K180822) received a 510(k) decision of Substantially Equivalent on January 28, 2019, 304 days after the submission was received.
What is the product code of K180822?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.