VariLift-C

GUDID 00813210020054

The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, expandable device with an interior expansion plate, and is grooved and fluted with large graft windows positioned between each of its four quadrants that provide bony contact with the endplates. VariLift-C may be used with or without supplemental fixation. VariLift-C is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six weeks of non-operative treatment prior to treatment with VariLift-C. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. The VariLift-C is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone.

WENZEL SPINE, INC.

Metallic spinal interbody fusion cage
Primary Device ID00813210020054
NIH Device Record Keyf3e1a16c-4480-483d-a0b6-8c5ed7356d01
Commercial Distribution StatusIn Commercial Distribution
Brand NameVariLift-C
Version Model NumberCIC1-7.5-12-00
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

Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Outer Diameter7.5 Millimeter
Length12 Millimeter
Outer Diameter7.5 Millimeter
Length12 Millimeter
Outer Diameter7.5 Millimeter
Length12 Millimeter
Outer Diameter7.5 Millimeter
Length12 Millimeter
Outer Diameter7.5 Millimeter
Length12 Millimeter
Outer Diameter7.5 Millimeter
Length12 Millimeter
Outer Diameter7.5 Millimeter
Length12 Millimeter
Outer Diameter7.5 Millimeter
Length12 Millimeter
Outer Diameter7.5 Millimeter
Length12 Millimeter
Outer Diameter7.5 Millimeter
Length12 Millimeter
Outer Diameter7.5 Millimeter
Length12 Millimeter
Outer Diameter7.5 Millimeter
Length12 Millimeter
Outer Diameter7.5 Millimeter
Length12 Millimeter
Outer Diameter7.5 Millimeter
Length12 Millimeter
Outer Diameter7.5 Millimeter
Length12 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
GS100813210020054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

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 Date2016-05-16

On-Brand Devices [VariLift-C]

00813210020856The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping,
00813210020849The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping,
00813210020832The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping,
00813210020788Expander
00813210020771Retainer
00813210020764Inserter
00813210020719Expansion Wrench, T-Handle
00813210020702Insertion Wrench, T-Handle
00813210020252Removal Screwdriver
00813210020221Expansion Wrench
00813210020214Locking Wrench
00813210020207Insertion Wrench
00813210020061The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping,
00813210020054The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping,
00813210020047The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping,
00813210020030The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping,
00813210021341VariLift-C Instrument Case
00813210020825VariLift-C Unlocking Rod
00813210020818VariLift-C 10mm Trial
00813210020801VariLift-C 09mm Trial
00813210020795VariLift-C 08mm Trial
00813210020269Graft Ejector
00813210020245Tap, 9.0mm
00813210020238Tap, 7.5mm
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