Catalog Number

80-4004/4545

Brand Name

CorticaLINK

Version/Model Number

80-4004/4545

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

K160722

Product Code

MNH

Product Code Name

Orthosis, Spondylolisthesis Spinal Fixation

Public Device Record Key

32526247-4bb8-417e-8304-e2f5fab74ac7

Public Version Date

November 22, 2018

Public Version Number

2

DI Record Publish Date

July 06, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-