Fixion Nailing System - Cortical screw for use with femoral nails - CARBOFIX ORTHOPEDICS LTD

Duns Number:649185170

Device Description: Cortical screw for use with femoral nails

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

9916090

Brand Name

Fixion Nailing System

Version/Model Number

Cortical Screw

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

HSB

Product Code Name

Rod, Fixation, Intramedullary And Accessories

Device Record Status

Public Device Record Key

d3bbc07a-efe0-47fe-9e16-17c50341477d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 22, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CARBOFIX ORTHOPEDICS LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1387