Catalog Number

VBR3527565

Brand Name

CarboClear Vertebral Body Replacement System

Version/Model Number

VBR Spacer

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

K192214

Product Code

MQP

Product Code Name

Spinal Vertebral Body Replacement Device

Public Device Record Key

461e848a-ac7b-450b-af61-2d5a94264da9

Public Version Date

October 19, 2020

Public Version Number

3

DI Record Publish Date

November 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-