Catalog Number

1301-1010-C

Brand Name

United Hip System, Center Hole Screw & Plug, Cemented

Version/Model Number

1301-1010-C

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

K050262

Product Code

LWJ

Product Code Name

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

Public Device Record Key

f3e3a04e-66a3-4333-b623-20b1aa66a990

Public Version Date

August 03, 2018

Public Version Number

4

DI Record Publish Date

October 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-