Catalog Number

530-075-30

Brand Name

eZ-Fix

Version/Model Number

530-075-30

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

K052196

Product Code

JDW

Product Code Name

Pin, Fixation, Threaded

Public Device Record Key

9d9f9e31-e413-4c16-a931-13ad7466d675

Public Version Date

November 23, 2021

Public Version Number

4

DI Record Publish Date

June 22, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-