Catalog Number

AXTi6525

Brand Name

AxTiHA®

Version/Model Number

AXTi6525

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

Product Code

OVD

Product Code Name

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Public Device Record Key

3e2d9547-900d-4272-b8a2-64e2be09dd0f

Public Version Date

September 01, 2021

Public Version Number

3

DI Record Publish Date

August 31, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-