VariLift-C Cervical Interbody Fusion System
FDA 510(k) K262595 · Wenzel Spine, Inc.
510(k) numberK262595
Submission
- Device name
- VariLift-C Cervical Interbody Fusion System
- Applicant
- Wenzel Spine, Inc.
Austin, TX, US - Received
- July 27, 2026
- Decision date
- August 26, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODP – Intervertebral Fusion Device With Bone Graft, Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Other 510(k)s with product code ODP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262489 | BluEX Cervical Expandable Cage SystemODP · Special | L&K BIOMED Co., Ltd. | 08/18/2026SE |
| K253041 | 3d Cage CervicalODP · Traditional | Fims Co., Ltd. | 07/23/2026SE |
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…ODP · Special | Stryker Spine | 07/17/2026SE |
| K254130 | C.A. Medical Interbody Fusion SystemODP · Special | C.A. Medical, LLC | 07/08/2026SE |
| K260840 | BluEX Cervical Expandable Cage SystemODP · Traditional | L&K BIOMED Co., Ltd. | 05/16/2026SE |
| K260850 | Osteomni Spinal Cages SystemODP · Traditional | Osteomni, Inc. | 05/12/2026SE |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemODP · Special | Zsfab, Inc. | 04/24/2026SE |
| K253260 | ORIO-3D Cage SystemODP · Traditional | SpineCraft | 04/16/2026SE |
| K260340 | HC Biologics Osteopoint PEEK Cages, HC Biologics Osteopoint Cervical PEEK Cages, HC…ODP · Traditional | HC Biologics, LLC | 04/13/2026SE |
| K242303 | Mod-CODP · Traditional | Orthomod, LLC | 04/01/2026SE |
More from Orthomod, LLC
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K180822 | VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemMAX · Traditional | 01/28/2019SE |
| 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-C Cervical Interbody Fusion System cleared by the FDA?
VariLift-C Cervical Interbody Fusion System (K262595) received a 510(k) decision of Substantially Equivalent on August 26, 2026, 30 days after the submission was received.
What is the product code of K262595?
The FDA product code is ODP – Intervertebral Fusion Device With Bone Graft, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.