Catalog Number

-

Brand Name

NEXXT MATRIXX® Stand Alone ALIF System

Version/Model Number

I61-TR3040-16-14

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K202230

Product Code

OVD

Product Code Name

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Public Device Record Key

0320e98e-5667-4d8a-a87c-548c36bff8ec

Public Version Date

March 04, 2021

Public Version Number

1

DI Record Publish Date

February 24, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-