Catalog Number

TPDG-FF-27ML

Brand Name

Forearm Plating System

Version/Model Number

Drill Guide, FreeFix™, 2.7mm

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

K200538

Product Code

HRS

Product Code Name

Plate, fixation, bone

Public Device Record Key

76285157-565f-40d1-b719-eb9c441bc92c

Public Version Date

December 03, 2020

Public Version Number

1

DI Record Publish Date

November 25, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-