Catalog Number

-

Brand Name

"UNITED" USTAR II Knee System

Version/Model Number

2115-3310

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

K190100

Product Code

KRO

Product Code Name

Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Public Device Record Key

37405235-9d6a-4f93-9b54-5ab434e96818

Public Version Date

December 31, 2019

Public Version Number

1

DI Record Publish Date

December 23, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-