Catalog Number

CES-287

Brand Name

EVOL®SI Joint Fusion System

Version/Model Number

CES-287

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

-

Product Code Name

-

Public Device Record Key

e96b9ad4-e99f-424a-b6e9-ce62395c9976

Public Version Date

August 26, 2019

Public Version Number

1

DI Record Publish Date

August 16, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-