VariLift-C - The Wenzel Spine VariLift-C Cervical Interbody - WENZEL SPINE, INC.

Duns Number:832543255

Device Description: The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tap

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More Product Details

Catalog Number

-

Brand Name

VariLift-C

Version/Model Number

CIC1-9.0-12-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K111123,K120603

Product Code Details

Product Code

ODP

Product Code Name

Intervertebral Fusion Device With Bone Graft, Cervical

Device Record Status

Public Device Record Key

b40711b3-7dff-4cb1-b76b-5d697f9aac02

Public Version Date

February 24, 2020

Public Version Number

4

DI Record Publish Date

May 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WENZEL SPINE, INC." Characteristics
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