Catalog Number

-

Brand Name

Vusion CS Plus

Version/Model Number

159-1609-07

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 24, 2016

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

K122588

Product Code

ODP

Product Code Name

Intervertebral fusion device with bone graft, cervical

Public Device Record Key

0acf7f8e-8fe3-4ccd-8715-3d28ea925a65

Public Version Date

February 24, 2020

Public Version Number

4

DI Record Publish Date

August 31, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-