Catalog Number

-

Brand Name

Zavation

Version/Model Number

Z-1018

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

-

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

K180673

Product Code

MQP

Product Code Name

Spinal Vertebral Body Replacement Device

Public Device Record Key

2939bca1-66e8-47b6-b596-53a2fdf31f52

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-