Catalog Number

5013-6034

Brand Name

EPIC™ Anterior Thoracolumbar Plate System

Version/Model Number

5013-6034

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

-

Product Code

KWQ

Product Code Name

Appliance, fixation, spinal intervertebral body

Public Device Record Key

fb7ba823-2153-4010-a369-f0ed4a74c31a

Public Version Date

March 10, 2022

Public Version Number

2

DI Record Publish Date

June 26, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-