Catalog Number

1501-1060

Brand Name

U1 Hip System, Bipolar Cup

Version/Model Number

1501-1060

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

K050269

Product Code

KWY

Product Code Name

Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Public Device Record Key

1ef9cd7a-9d6a-447a-94bb-c04108fe4021

Public Version Date

September 09, 2020

Public Version Number

5

DI Record Publish Date

October 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-