Catalog Number

54-12T-08U

Brand Name

Foot and Ankle Plating System

Version/Model Number

54-12T-08U

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

K172973

Product Code

HRS

Product Code Name

Plate, fixation, bone

Public Device Record Key

75d833a7-5d3d-47b4-996e-185d408aae1f

Public Version Date

November 15, 2019

Public Version Number

1

DI Record Publish Date

November 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-