Catalog Number

-

Brand Name

ORIA Zenith® Cervical Plate System

Version/Model Number

F070-CT45

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

K001535

Product Code

HWX

Product Code Name

TAP, BONE

Public Device Record Key

4658636b-6990-4ceb-86ee-fb5319ebff9f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-