Catalog Number

825M1535

Brand Name

Vital™ MIS Spinal Fixation System

Version/Model Number

825M1535

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

-

Product Code

NKB

Product Code Name

Thoracolumbosacral pedicle screw system

Public Device Record Key

b642e759-93ec-4561-bac2-dfc7cfa4a783

Public Version Date

March 10, 2022

Public Version Number

2

DI Record Publish Date

April 21, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-