Catalog Number

-

Brand Name

Jones-FX Jones Fracture System

Version/Model Number

JS4535

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 29, 2017

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

-

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

8d1f77ab-352e-438b-b617-0d0d0ef3132f

Public Version Date

December 15, 2020

Public Version Number

3

DI Record Publish Date

October 17, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-