Catalog Number

HXI-48-0004

Brand Name

Sure-Lok Extended Tab Pedicle Screw System

Version/Model Number

HXI-48-0004

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

-

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

HXI

Product Code Name

Passer, Wire, Orthopedic

Public Device Record Key

f75e618b-6f58-49fa-935d-3aa8362a56a8

Public Version Date

April 05, 2019

Public Version Number

1

DI Record Publish Date

March 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-