Catalog Number

-

Brand Name

Invictus

Version/Model Number

18620-55-40

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

K203125

Product Code

NKG

Product Code Name

Posterior cervical screw system

Public Device Record Key

3ba4b48c-b9a6-4821-822d-33fc3a26aec2

Public Version Date

June 03, 2022

Public Version Number

1

DI Record Publish Date

May 26, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-