VariLift-L

GUDID 00813210020016

The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The VariLift-L is a grooved and fluted device with large graft windows positioned each of its four quadrants that provide bony contact with the endplates. VariLift-L is designed to be implanted bi-laterally via posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift-L may be implanted with or without supplemental fixation and is intended for use with autograft to facilitate fusion. VariLift-L is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

WENZEL SPINE, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00813210020016
• NIH Device Record Key: db00ffc4-8759-4177-9908-2030cfb5565b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VariLift-L
• Version Model Number: CIE2-13-24-00
• 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: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 24 Millimeter
• Outer Diameter: 13 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	00813210020016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131296

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: 2015-12-17

On-Brand Devices [VariLift-L]

• 00813210020757: 13-15mm Extended Inserter
• 00813210020740: 10-12mm Extended Inserter
• 00813210020566: Inserter, 10mm-12mm, Molded Handle
• 00813210020559: 9/11mm Retainer
• 00813210020474: Reducer, Molded Handle
• 00813210020467: Expander
• 00813210020450: 13/15mm Retainer
• 00813210020443: Inserter, 13mm-15mm, Molded Handle
• 00813210020436: 13-15mm TR8 Extended Retainer
• 00813210020429: 10-12mm TR8 Extended Retainer
• 00813210020412: 24/28mm Extended Expander
• 00813210020405: Extended Reducer, Ti Handle
• 00813210020399: 13-15mm Extended Inserter
• 00813210020382: 10-12mm Extended Inserter
• 00813210020023: The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device wi
• 00813210020016: The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device wi
• 00813210020009: The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device wi
• 00813210020634: 15mm Threaded Trial
• 00813210020627: 14mm Threaded Trial
• 00813210020610: 13mm Threaded Trial
• 00813210020603: 12mm Threaded Trial
• 00813210020597: 11mm Threaded Trial
• 00813210020580: 10mm Threaded Trial
• 00813210020573: Retainer Alignment Guide
• 00813210020542: Inserter Alignment Guide
• 00813210020306: Insertion Wrench Alignment Guide