Catalog Number

04647127S

Brand Name

Zero-P VA

Version/Model Number

04.647.127S

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

K112068

Product Code

OVE

Product Code Name

Intervertebral fusion device with integrated fixation, cervical

Public Device Record Key

bb86cee0-90ef-48d3-a4f7-167d92d4ec84

Public Version Date

April 26, 2022

Public Version Number

5

DI Record Publish Date

September 14, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-