Catalog Number

3801.2406

Brand Name

Kinos Axiom

Version/Model Number

3801.2406

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K192778

Product Code

HSN

Product Code Name

Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Public Device Record Key

8b1dc56b-0e3d-45e6-b16e-e5ff0ae65fb8

Public Version Date

October 20, 2020

Public Version Number

1

DI Record Publish Date

October 12, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-