Catalog Number

CZ8535CT

Brand Name

VERTEFIX

Version/Model Number

CZ8535CT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K080075

Product Code

KWP

Product Code Name

Appliance, Fixation, Spinal Interlaminal

Public Device Record Key

3ef00e2a-574a-41fc-b270-c5835dc4f229

Public Version Date

February 03, 2020

Public Version Number

1

DI Record Publish Date

January 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-