Catalog Number

-

Brand Name

COLOSSEUM

Version/Model Number

656.102

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

K190147

Product Code

MQP

Product Code Name

Spinal vertebral body replacement device

Public Device Record Key

37a79efe-bc76-4ac2-845b-4244c8a288ce

Public Version Date

January 02, 2020

Public Version Number

1

DI Record Publish Date

December 25, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-