Catalog Number

8829403015

Brand Name

MOBIO™ Total Knee System

Version/Model Number

8829403015

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NBH

Product Code Name

Accessories, Arthroscopic

Public Device Record Key

86580fc2-da6b-49c5-b255-6f8a43f968dd

Public Version Date

April 06, 2020

Public Version Number

2

DI Record Publish Date

May 24, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-