Catalog Number

-

Brand Name

Invictus

Version/Model Number

18702-35-55

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

a1a9a52f-1226-4745-a7b8-8f6a55e7d505

Public Version Date

March 28, 2022

Public Version Number

1

DI Record Publish Date

March 18, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-