Catalog Number

-

Brand Name

Matrixx System

Version/Model Number

50M-1214-10-09-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)

Yes

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

fcb46b0e-39a2-4baa-8bb2-bc254d479a04

Public Version Date

December 02, 2020

Public Version Number

1

DI Record Publish Date

November 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-