Catalog Number

-

Brand Name

Matrixx System

Version/Model Number

53-1214-70-6-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

K193412

Product Code

MQP

Product Code Name

Spinal Vertebral Body Replacement Device

Public Device Record Key

fc09986a-f4a9-44e6-bbda-c666a502fee8

Public Version Date

September 21, 2020

Public Version Number

1

DI Record Publish Date

September 11, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-