Catalog Number

-

Brand Name

2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Narrow (Right), 6 hea

Version/Model Number

TI-546.003RS

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

K211324

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

0c9a17af-13ac-442e-a687-22ff92207a54

Public Version Date

May 05, 2022

Public Version Number

1

DI Record Publish Date

April 27, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-