Catalog Number

-

Brand Name

Matrixx System

Version/Model Number

50M-1416P-14-SP

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K171140

Product Code

MQP

Product Code Name

Spinal Vertebral Body Replacement Device

Public Device Record Key

bd6942ab-fa2c-46be-98e8-e30b39c240e8

Public Version Date

February 24, 2020

Public Version Number

2

DI Record Publish Date

December 07, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-