| Primary Device ID | 00813210020191 |
| NIH Device Record Key | e16a6e53-1697-4442-9120-9ae7880764e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VariLift-LX |
| Version Model Number | CIE2-A013-C01 |
| Company DUNS | 832543255 |
| Company Name | WENZEL SPINE, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Phone | 855-936-9351 |
| info@wenzelspine.com | |
| Phone | 855-936-9351 |
| info@wenzelspine.com | |
| Phone | 855-936-9351 |
| info@wenzelspine.com | |
| Phone | 855-936-9351 |
| info@wenzelspine.com | |
| Phone | 855-936-9351 |
| info@wenzelspine.com | |
| Phone | 855-936-9351 |
| info@wenzelspine.com | |
| Phone | 855-936-9351 |
| info@wenzelspine.com | |
| Phone | 855-936-9351 |
| info@wenzelspine.com | |
| Phone | 855-936-9351 |
| info@wenzelspine.com | |
| Phone | 855-936-9351 |
| info@wenzelspine.com | |
| Phone | 855-936-9351 |
| info@wenzelspine.com | |
| Phone | 855-936-9351 |
| info@wenzelspine.com | |
| Phone | 855-936-9351 |
| info@wenzelspine.com | |
| Phone | 855-936-9351 |
| info@wenzelspine.com | |
| Phone | 855-936-9351 |
| info@wenzelspine.com | |
| Phone | 855-936-9351 |
| info@wenzelspine.com | |
| Phone | 855-936-9351 |
| info@wenzelspine.com | |
| Phone | 855-936-9351 |
| info@wenzelspine.com | |
| Phone | 855-936-9351 |
| info@wenzelspine.com | |
| Phone | 855-936-9351 |
| info@wenzelspine.com | |
| Phone | 855-936-9351 |
| info@wenzelspine.com | |
| Phone | 855-936-9351 |
| info@wenzelspine.com | |
| Phone | 855-936-9351 |
| info@wenzelspine.com | |
| Phone | 855-936-9351 |
| info@wenzelspine.com | |
| Phone | 855-936-9351 |
| info@wenzelspine.com | |
| Phone | 855-936-9351 |
| info@wenzelspine.com | |
| Phone | 855-936-9351 |
| info@wenzelspine.com | |
| Phone | 855-936-9351 |
| info@wenzelspine.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813210020191 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00813210020191]
Moist Heat or Steam Sterilization
[00813210020191]
Moist Heat or Steam Sterilization
[00813210020191]
Moist Heat or Steam Sterilization
[00813210020191]
Moist Heat or Steam Sterilization
[00813210020191]
Moist Heat or Steam Sterilization
[00813210020191]
Moist Heat or Steam Sterilization
[00813210020191]
Moist Heat or Steam Sterilization
[00813210020191]
Moist Heat or Steam Sterilization
[00813210020191]
Moist Heat or Steam Sterilization
[00813210020191]
Moist Heat or Steam Sterilization
[00813210020191]
Moist Heat or Steam Sterilization
[00813210020191]
Moist Heat or Steam Sterilization
[00813210020191]
Moist Heat or Steam Sterilization
[00813210020191]
Moist Heat or Steam Sterilization
[00813210020191]
Moist Heat or Steam Sterilization
[00813210020191]
Moist Heat or Steam Sterilization
[00813210020191]
Moist Heat or Steam Sterilization
[00813210020191]
Moist Heat or Steam Sterilization
[00813210020191]
Moist Heat or Steam Sterilization
[00813210020191]
Moist Heat or Steam Sterilization
[00813210020191]
Moist Heat or Steam Sterilization
[00813210020191]
Moist Heat or Steam Sterilization
[00813210020191]
Moist Heat or Steam Sterilization
[00813210020191]
Moist Heat or Steam Sterilization
[00813210020191]
Moist Heat or Steam Sterilization
[00813210020191]
Moist Heat or Steam Sterilization
[00813210020191]
Moist Heat or Steam Sterilization
[00813210020191]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-04-23 |
| Device Publish Date | 2016-09-19 |
| 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 |