Catalog Number

UU041-01-1317

Brand Name

Solidity Vertebral Body Replacement

Version/Model Number

UU041-01-1317

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

K181921

Product Code

MQP

Product Code Name

Spinal Vertebral Body Replacement Device

Public Device Record Key

d0c64aa8-cd50-48fb-9c05-8f04a827d3ea

Public Version Date

June 25, 2021

Public Version Number

2

DI Record Publish Date

December 27, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-