Catalog Number

-

Brand Name

TrellOss™

Version/Model Number

130N3001

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

K171140

Product Code

MQP

Product Code Name

Spinal Vertebral Body Replacement Device

Public Device Record Key

8777ad63-5f04-4cfa-a9ad-62d1c64431df

Public Version Date

May 21, 2019

Public Version Number

1

DI Record Publish Date

May 13, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-