Catalog Number

64-2216-10-0L

Brand Name

Unison®-C Anterior Cervical Fixation System

Version/Model Number

64-2216-10-0L

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

K170830

Product Code

OVE

Product Code Name

Intervertebral fusion device with integrated fixation, cervical

Public Device Record Key

fa1db6b9-bf8d-4172-b3ce-c6bc5a7f77ee

Public Version Date

October 14, 2021

Public Version Number

4

DI Record Publish Date

July 03, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-