Catalog Number

-

Brand Name

"UNITED" USTAR II Hip System

Version/Model Number

1115-1217

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

0a9a8b2f-f36c-477b-8dac-cb6d3a8b4a42

Public Version Date

March 03, 2020

Public Version Number

1

DI Record Publish Date

February 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-