Catalog Number

9600314

Brand Name

TRUFIX Bone Fixation System

Version/Model Number

9600314

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,K951392

Product Code

OAT

Product Code Name

Implant, endosseous, orthodontic

Public Device Record Key

93f34482-4770-47aa-b240-60edba0905eb

Public Version Date

October 23, 2019

Public Version Number

5

DI Record Publish Date

December 28, 2017

Package DI Number

10614950007070

Quantity per Package

10

Contains DI Package

00614950007073

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tyvec Bag