Catalog Number

MC2-004110

Brand Name

Mariner MCT

Version/Model Number

MC2-004110

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 15, 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

0d115833-d987-45b0-b991-8782900b3053

Public Version Date

April 15, 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

-