Catalog Number

ZF-T10

Brand Name

Vilex Fibula Tool

Version/Model Number

ZF-T10

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

K151456

Product Code

HSB

Product Code Name

Rod, Fixation, Intramedullary And Accessories

Public Device Record Key

8527b6f9-6702-418f-b789-5172f07e5acd

Public Version Date

May 27, 2020

Public Version Number

5

DI Record Publish Date

August 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-