VariLift-C
VariLift-C is a self-tapping, expandable cervical interbody fusion device. An internal sliding wedge expands its cylindrical-ovoid body, which is shaped to fit between the cervical…
VariLift-C is a self-tapping, expandable cervical interbody fusion device. An internal sliding wedge expands its cylindrical-ovoid body, which is shaped to fit between the cervical vertebral endplates.
The titanium-alloy body is grooved and fluted, with large graft windows between four endplate-contacting quadrants. It accommodates autograft and is supplied sterile.
Listed Item
The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, expandable device with an interior expansion plate, and is grooved and fluted with large graft windows positioned between each of its four quadrants that provide bony contact with the endplates. VariLift-C may be used with or without supplemental fixation. VariLift-C is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six weeks of non-operative treatment prior to treatment with VariLift-C. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. The VariLift-C is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone.
Cervical Implant Configuration
One implant or a pair may be placed through an anterior approach at a single level from C3 to C7. This configuration may be used with or without supplemental fixation, as specified for the system. The implant material is Ti-6Al-4V ELI titanium alloy.
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Shanghai Sanyou Medical Co., Ltd. | Shanghai | Shanghai | Manufacturer | 6 |
Record
| Listed by | Wenzel Spine, United States |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K120603 |
| Record published | 2017-08-07 |
| Record revised | 2024-09-11 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Room Temperature; Keep Dry |
| Sizes | Length 12 mm; outer diameter 7.5 to 9 mm; height 8 to 10 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CIC2-A742 | In distribution | |
| CIC1-A743 | In distribution | |
| CIC1-9.0-12-00 | Outer Diameter 9.0 mm | In distribution |
| CIC1-A741-C01 | In distribution | |
| CIC1-A741 | In distribution | |
| CIC1-7.5-12-BP | Length 12 mm | In distribution |
| CIC1-9.0-12-BP | Length 12 mm | In distribution |
| CIC1-A747 | In distribution | |
| CIC1-A742 | In distribution | |
| CIC2-10-12-00 | Length 12 mm | In distribution |
| CIC1-A743-C01 | In distribution | |
| CIC2-A741 | In distribution | |
| CIC2-08-12-00 | Length 12 mm | In distribution |
| CIC1-7.5-12-00 | Outer Diameter 7.5 mm | In distribution |
| CIC2-09-12-00 | Length 12 mm | In distribution |
| CIC2-A743 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Latitude-C AM™ Cervical Interbody Fusion System | Degen Medical | 1,529 |
| IdentiTi | Alphatec Spine, Inc. | 1,390 |
| Zavation | Zavation | 1,357 |
| IVA Cage Ti | Diomedical Co., Ltd. | 1,202 |
| Latitude-C Cervical Interbody Spacer System | Degen Medical | 1,185 |
| Peridot Anterior Cervical Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | 1,056 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,017 |
| Valeo Spacer System | Sintx Technologies Inc. | 918 |
| Cascadia™ Interbody System | VB Spine LLC | 823 |
| CoRoent | Nuvasive, Inc. | 815 |
| Tyber Medical | Tyber Medical | 740 |
| Matisse Anterior Cervical Interbody Fusion Cage System | CTL Medical Corporation | 577 |
Showing 12 of 938. All products under Intervertebral Fusion Device With Bone Graft, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K262595 | 2026-08-26 |
| K231076 | 2023-09-27 |
| K120603 | 2013-01-29 |
| K111123 | 2011-12-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.