VariLift-L

GUDID 00813210020009

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 ID00813210020009
NIH Device Record Key190f9517-6017-46cb-834d-1aab7ceb075e
Commercial Distribution StatusIn Commercial Distribution
Brand NameVariLift-L
Version Model NumberCIE2-11-24-00
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

Device Dimensions

Outer Diameter11 Millimeter
Outer Diameter11 Millimeter
Outer Diameter11 Millimeter
Outer Diameter11 Millimeter
Length24 Millimeter
Outer Diameter11 Millimeter
Length24 Millimeter
Outer Diameter11 Millimeter
Length24 Millimeter
Outer Diameter11 Millimeter
Length24 Millimeter
Outer Diameter11 Millimeter
Length24 Millimeter
Outer Diameter11 Millimeter
Length24 Millimeter
Outer Diameter11 Millimeter
Length24 Millimeter
Outer Diameter11 Millimeter
Length24 Millimeter
Outer Diameter11 Millimeter
Length24 Millimeter
Outer Diameter11 Millimeter
Length24 Millimeter
Outer Diameter11 Millimeter
Length24 Millimeter
Outer Diameter11 Millimeter
Length24 Millimeter
Outer Diameter11 Millimeter
Length24 Millimeter
Outer Diameter11 Millimeter
Length24 Millimeter
Outer Diameter11 Millimeter
Length24 Millimeter
Outer Diameter11 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
GS100813210020009 [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 Date2015-12-17

On-Brand Devices [VariLift-L]

0081321002075713-15mm Extended Inserter
0081321002074010-12mm Extended Inserter
00813210020566Inserter, 10mm-12mm, Molded Handle
008132100205599/11mm Retainer
00813210020474Reducer, Molded Handle
00813210020467Expander
0081321002045013/15mm Retainer
00813210020443Inserter, 13mm-15mm, Molded Handle
0081321002043613-15mm TR8 Extended Retainer
0081321002042910-12mm TR8 Extended Retainer
0081321002041224/28mm Extended Expander
00813210020405Extended Reducer, Ti Handle
0081321002039913-15mm Extended Inserter
0081321002038210-12mm Extended Inserter
00813210020023The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device wi
00813210020016The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device wi
00813210020009The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device wi
0081321002063415mm Threaded Trial
0081321002062714mm Threaded Trial
0081321002061013mm Threaded Trial
0081321002060312mm Threaded Trial
0081321002059711mm Threaded Trial
0081321002058010mm Threaded Trial
00813210020573Retainer Alignment Guide
00813210020542Inserter Alignment Guide
00813210020306Insertion Wrench Alignment Guide

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