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 ID00813210020115
NIH Device Record Key0770e404-07ea-4830-b951-07000717e125
Commercial Distribution StatusIn Commercial Distribution
Brand NameVariLift-LX
Version Model NumberCIE3-15-24-00
Company DUNS832543255
Company NameWENZEL SPINE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com

Device Dimensions

Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Length24 Millimeter
Outer Diameter15 Millimeter
Length24 Millimeter
Outer Diameter15 Millimeter
Length24 Millimeter
Outer Diameter15 Millimeter
Length24 Millimeter
Outer Diameter15 Millimeter
Length24 Millimeter
Outer Diameter15 Millimeter
Length24 Millimeter
Outer Diameter15 Millimeter
Length24 Millimeter
Outer Diameter15 Millimeter
Length24 Millimeter
Outer Diameter15 Millimeter
Length24 Millimeter
Outer Diameter15 Millimeter
Length24 Millimeter
Outer Diameter15 Millimeter
Length24 Millimeter
Outer Diameter15 Millimeter
Length24 Millimeter
Outer Diameter15 Millimeter
Length24 Millimeter
Outer Diameter15 Millimeter
Length24 Millimeter
Outer Diameter15 Millimeter
Length24 Millimeter
Outer Diameter15 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature; Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100813210020115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2016-02-18

On-Brand Devices [VariLift-LX]

00813210020696Expander, 28mm
00813210020689Expander, 24mm
00813210020658Extended End Cap Driver
00813210020641End Cap Driver
00813210020375Retainer, 13mm-15mm
00813210020368Retainer, 10mm-12mm
00813210020351Reducer, Hurricane Handle
00813210020344Inserter, 13mm-15mm, Hurricane Handle
00813210020337Inserter, 10mm-12mm, Hurricane Handle
0081321002019113-15mm Inserter, with Distal Depth Marks
0081321002018410-12mm Inserter, with Distal Depth Marks
00813210020177The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with a
00813210020160The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with a
00813210020153The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with a
00813210020146The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with a
00813210020139The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with a
00813210020122The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with a
00813210020115The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with a
00813210020108The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device wi
00813210020092The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with a
00813210020085The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with a
00813210020078The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with a
00813210020672MI Graft Impactor
00813210020665MI Graft Funnel
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