VariLift-C

GUDID 00813210020832

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.

WENZEL SPINE, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00813210020832
• NIH Device Record Key: a82e72e4-37d1-4591-b2d6-8c2a6c1b30e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VariLift-C
• Version Model Number: CIC2-08-12-00
• Company DUNS: 832543255
• Company Name: WENZEL SPINE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com

Device Dimensions

• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature; Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813210020832 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120603

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2017-08-07

On-Brand Devices [VariLift-C]

• 00813210020856: The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping,
• 00813210020849: The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping,
• 00813210020832: The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping,
• 00813210020788: Expander
• 00813210020771: Retainer
• 00813210020764: Inserter
• 00813210020719: Expansion Wrench, T-Handle
• 00813210020702: Insertion Wrench, T-Handle
• 00813210020252: Removal Screwdriver
• 00813210020221: Expansion Wrench
• 00813210020214: Locking Wrench
• 00813210020207: Insertion Wrench
• 00813210020061: The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping,
• 00813210020054: The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping,
• 00813210020047: The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping,
• 00813210020030: The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping,
• 00813210021341: VariLift-C Instrument Case
• 00813210020825: VariLift-C Unlocking Rod
• 00813210020818: VariLift-C 10mm Trial
• 00813210020801: VariLift-C 09mm Trial
• 00813210020795: VariLift-C 08mm Trial
• 00813210020269: Graft Ejector
• 00813210020245: Tap, 9.0mm
• 00813210020238: Tap, 7.5mm