Catalog Number

-

Brand Name

General Instruments

Version/Model Number

CI-10275-10141207

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

K202812

Product Code

OVE

Product Code Name

Intervertebral fusion device with integrated fixation, cervical

Public Device Record Key

b5c06148-f9d7-40c6-9da2-6e197f7ee485

Public Version Date

October 06, 2022

Public Version Number

2

DI Record Publish Date

July 28, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-