Catalog Number

172.11

Brand Name

Traufix osteosynthesis, osteotomy, and arthrodesis devices

Version/Model Number

172.11

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

K201510

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

531b5a38-de06-4696-887b-2735ea38b59a

Public Version Date

October 14, 2022

Public Version Number

2

DI Record Publish Date

September 20, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-