Catalog Number

76-4540

Brand Name

Daytona

Version/Model Number

76-4540

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

K163604

Product Code

NKB

Product Code Name

Thoracolumbosacral pedicle screw system

Public Device Record Key

e2408d2d-81b6-4450-9c05-9305d192c13d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-