Catalog Number

MC2-003011

Brand Name

Mariner MCT

Version/Model Number

MC2-003011

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 19, 2022

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

-

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

K173882

Product Code

NKB

Product Code Name

Thoracolumbosacral pedicle screw system

Public Device Record Key

ebbaf751-1cd2-4c32-b200-9b42f3f3f05f

Public Version Date

April 19, 2022

Public Version Number

2

DI Record Publish Date

January 09, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-