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VariLift-L

FDA UDI

Class II (US FDA UDI)

by Wenzel Spine

Identity

Trade Name
VariLift-L FDA UDI
Generic Name
Metallic spinal interbody fusion cage FDA UDI
Device Name
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. FDA UDI
Model / Reference
CIE2-13-24-00 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00813210020016 FDA UDI
510(k) Number
K131296 FDA UDI
FDA Product Code
MAX 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 — 24 Millimeter FDA UDI
Outer Diameter — 13 Millimeter FDA UDI

Category: Metallic spinal interbody fusion cage

VariLift-L 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

K131296 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 db00ffc4-8759-4177-9908-2030cfb5565b 37 fields · synced May 31, 2026