Catalog Number

-

Brand Name

Revolution External Plating System

Version/Model Number

624004

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

K181630

Product Code

KTT

Product Code Name

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Public Device Record Key

1d07ea41-1309-49e9-9951-21eb8d8770c6

Public Version Date

February 07, 2022

Public Version Number

3

DI Record Publish Date

August 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-