Catalog Number

-

Brand Name

Trabis®

Version/Model Number

P15-010-11

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K173893

Product Code

PLR

Product Code Name

Spinal Vertebral Body Replacement Device - Cervical

Public Device Record Key

4fa7b0af-9b29-4ace-a998-9dc7b34532fb

Public Version Date

February 24, 2020

Public Version Number

2

DI Record Publish Date

September 11, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-