Catalog Number

1601-322-090

Brand Name

Kyocera Medical Technologies, Inc.

Version/Model Number

Cemented Hip

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

K141370

Product Code

JDI

Product Code Name

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

Public Device Record Key

0fa4a96c-8bf8-496b-88f1-362edfb31a6b

Public Version Date

July 23, 2019

Public Version Number

5

DI Record Publish Date

October 29, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-