Catalog Number

TP3106

Brand Name

CONTOURS PROXIMAL HUMERAL PLATE (PHP) & LSP TITANIUM HUMERAL PLATE

Version/Model Number

1

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

K122541

Product Code

KTW

Product Code Name

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

Public Device Record Key

f78e568c-d21a-4348-a466-c10dd92c8fa2

Public Version Date

October 05, 2018

Public Version Number

4

DI Record Publish Date

April 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-