Catalog Number

-

Brand Name

Zavation

Version/Model Number

170-2011

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

K141005

Product Code

OVE

Product Code Name

Intervertebral Fusion Device With Integrated Fixation, Cervical

Public Device Record Key

f166db31-2d22-4703-9960-2f2087469f14

Public Version Date

May 27, 2020

Public Version Number

1

DI Record Publish Date

May 19, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-