Catalog Number

-

Brand Name

Axi+Line Bunion Correction System

Version/Model Number

AXJ-125R

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K152548

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

586b247c-eee2-4a2b-b14d-8af3ebea5f5f

Public Version Date

September 23, 2022

Public Version Number

2

DI Record Publish Date

February 02, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-