VariLift-LX

GUDID 00813210020115

The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The VariLift-LX is a grooved and fluted device with large graft windows positioned each of its four quadrants that provide bony contact with the endplates. VariLift-LX is designed to be implanted bi-laterally via a PLIF or TLIF approach, and may be implanted with or without supplemental fixation.

WENZEL SPINE, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00813210020115
• NIH Device Record Key: 0770e404-07ea-4830-b951-07000717e125
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VariLift-LX
• Version Model Number: CIE3-15-24-00
• 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

• Outer Diameter: 15 Millimeter
• Outer Diameter: 15 Millimeter
• Outer Diameter: 15 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 15 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 15 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	00813210020115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151900

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

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: 2016-02-18

On-Brand Devices [VariLift-LX]

• 00813210020696: Expander, 28mm
• 00813210020689: Expander, 24mm
• 00813210020658: Extended End Cap Driver
• 00813210020641: End Cap Driver
• 00813210020375: Retainer, 13mm-15mm
• 00813210020368: Retainer, 10mm-12mm
• 00813210020351: Reducer, Hurricane Handle
• 00813210020344: Inserter, 13mm-15mm, Hurricane Handle
• 00813210020337: Inserter, 10mm-12mm, Hurricane Handle
• 00813210020191: 13-15mm Inserter, with Distal Depth Marks
• 00813210020184: 10-12mm Inserter, with Distal Depth Marks
• 00813210020177: The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with a
• 00813210020160: The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with a
• 00813210020153: The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with a
• 00813210020146: The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with a
• 00813210020139: The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with a
• 00813210020122: The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with a
• 00813210020115: The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with a
• 00813210020108: The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device wi
• 00813210020092: The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with a
• 00813210020085: The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with a
• 00813210020078: The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with a
• 00813210020672: MI Graft Impactor
• 00813210020665: MI Graft Funnel