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VariLift-C

FDA UDI

Class II (US FDA UDI)

by Wenzel Spine

Identity

Trade Name
VariLift-C FDA UDI
Generic Name
Metallic spinal interbody fusion cage FDA UDI
Device Name
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. FDA UDI
Model / Reference
CIC2-08-12-00 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00813210020832 FDA UDI
510(k) Number
K120603 FDA UDI
FDA Product Code
ODP FDA UDI
GMDN Term
Metallic spinal interbody fusion cage FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 12 Millimeter FDA UDI
Height — 8.0 Millimeter FDA UDI

Category: Metallic spinal interbody fusion cage

VariLift-C by Wenzel Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metallic spinal interbody fusion cage.

Cleared under the same submission

K120603 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wenzel Spine

Sources (1)

  • FDA UDI a82e72e4-37d1-4591-b2d6-8c2a6c1b30e4 37 fields · synced Jun 6, 2026