Catalog Number

ART-12-380

Brand Name

Talon™ DistalFix™ A/R Femoral Nail

Version/Model Number

ART12380

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K152295

Product Code

HSB

Product Code Name

Rod, Fixation, Intramedullary And Accessories

Public Device Record Key

cd4643d2-6ea8-49a1-94c9-5212faf87e06

Public Version Date

December 07, 2021

Public Version Number

1

DI Record Publish Date

November 29, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-