Catalog Number

E0016390-2

Brand Name

Ex-Fix

Version/Model Number

E0016390-2

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

K994143

Product Code

JDW

Product Code Name

PIN, FIXATION, THREADED

Public Device Record Key

adc37d5e-9968-4b8c-a045-7dc0b998582e

Public Version Date

November 23, 2021

Public Version Number

2

DI Record Publish Date

February 25, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-