Catalog Number

45437401

Brand Name

TRUFIX Bone Fixation System

Version/Model Number

45437401

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

K951392

Product Code

OAT

Product Code Name

Implant, endosseous, orthodontic

Public Device Record Key

da1205dc-ab5f-4189-8acd-03b63cb6420c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-