Catalog Number

AXTi203630

Brand Name

AxTiHA®

Version/Model Number

AXTi203630

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K182139,K201614,K182139,K201614

Product Code

OVD

Product Code Name

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Public Device Record Key

4df0247c-e8ec-4e65-a75c-54f8f012f92e

Public Version Date

September 01, 2021

Public Version Number

3

DI Record Publish Date

August 31, 2019

Package DI Number

M711AXTI2036301

Quantity per Package

1

Contains DI Package

M711AXTI2036300

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton