Duns Number:832543255
Device Description: The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device 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.
Catalog Number
-
Brand Name
VariLift-LX
Version/Model Number
CIE3-10-28-00
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K151900
Product Code
MAX
Product Code Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Public Device Record Key
6035b1a9-254b-42b3-bda7-ac3ff118f860
Public Version Date
February 24, 2020
Public Version Number
4
DI Record Publish Date
February 18, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 46 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |
| U | Unclassified | 9 |