Catalog Number

-

Brand Name

VBR

Version/Model Number

4378

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 15, 2017

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K072326

Product Code

MQP

Product Code Name

Spinal Vertebral Body Replacement Device

Public Device Record Key

e459fb06-669a-4f19-aa1f-ddc62c4896f0

Public Version Date

February 24, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-