Catalog Number

-

Brand Name

Matrixx System

Version/Model Number

I53-T2459

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K193412

Product Code

MQP

Product Code Name

Spinal Vertebral Body Replacement Device

Public Device Record Key

7def5f05-bfc8-424f-a525-5931140c7204

Public Version Date

May 26, 2021

Public Version Number

1

DI Record Publish Date

May 18, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-