Catalog Number

AXTi163614

Brand Name

AxTiHA®

Version/Model Number

AXTi163614

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

ba241bba-36c2-4ab2-bde2-9ba34c7ee242

Public Version Date

August 31, 2021

Public Version Number

3

DI Record Publish Date

August 31, 2019

Package DI Number

M711AXTI1636141

Quantity per Package

1

Contains DI Package

M711AXTI1636140

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton