VariLift-LX

GUDID 00813210020351

Reducer, Hurricane Handle

WENZEL SPINE, INC.

Orthopaedic implant/instrument dismantling device

• Primary Device ID: 00813210020351
• NIH Device Record Key: db63657c-470e-4362-a8c7-aa30dd2c8fdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VariLift-LX
• Version Model Number: CIE2-A014
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00813210020351 [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: true
• Device Is Sterile: false

[00813210020351]

Moist Heat or Steam Sterilization

[00813210020351]

Moist Heat or Steam Sterilization

[00813210020351]

Moist Heat or Steam Sterilization

[00813210020351]

Moist Heat or Steam Sterilization

[00813210020351]

Moist Heat or Steam Sterilization

[00813210020351]

Moist Heat or Steam Sterilization

[00813210020351]

Moist Heat or Steam Sterilization

[00813210020351]

Moist Heat or Steam Sterilization

[00813210020351]

Moist Heat or Steam Sterilization

[00813210020351]

Moist Heat or Steam Sterilization

[00813210020351]

Moist Heat or Steam Sterilization

[00813210020351]

Moist Heat or Steam Sterilization

[00813210020351]

Moist Heat or Steam Sterilization

[00813210020351]

Moist Heat or Steam Sterilization

[00813210020351]

Moist Heat or Steam Sterilization

[00813210020351]

Moist Heat or Steam Sterilization

[00813210020351]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-19

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