Catalog Number

5010.42.321

Brand Name

BIOLOX DELTA

Version/Model Number

5010.42.321

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

K141327

Product Code

JDI

Product Code Name

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

Public Device Record Key

d8517f4b-899d-47e1-acb9-92c2aa6f78e6

Public Version Date

June 07, 2021

Public Version Number

1

DI Record Publish Date

May 28, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-