Catalog Number

225921

Brand Name

Katalyst™ Bipolar Radial Head System

Version/Model Number

225921

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

-

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

K032806

Product Code

KWI

Product Code Name

PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Public Device Record Key

be96b143-b9b4-4f5f-9162-9d2993c6016b

Public Version Date

March 04, 2021

Public Version Number

3

DI Record Publish Date

May 11, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-