Catalog Number

-

Brand Name

Auxein Brand Vertaux 5.5 mm Pedicle Screw System

Version/Model Number

SP-343

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

K201457

Product Code

NKB

Product Code Name

Thoracolumbosacral Pedicle Screw System

Public Device Record Key

e7ac8da7-6cad-46a3-9f13-7de8e9dc368d

Public Version Date

July 16, 2021

Public Version Number

1

DI Record Publish Date

July 08, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-