Catalog Number

-

Brand Name

Vusion TS

Version/Model Number

551-5218

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

K062666

Product Code

MQP

Product Code Name

SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Public Device Record Key

46f6909d-8775-49e0-a4c0-1d97b52a546f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 15, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-