Catalog Number

350665

Brand Name

JAZZ System

Version/Model Number

Jazz Rod - Pre-bent Union Rod – L80

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K182771,K191217

Product Code

NKB

Product Code Name

Thoracolumbosacral Pedicle Screw System

Public Device Record Key

31dc0b5c-82dc-45f1-96d5-b10bcbca96d6

Public Version Date

September 26, 2019

Public Version Number

2

DI Record Publish Date

March 20, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-