Catalog Number

NK460

Brand Name

Biolox® forte

Version/Model Number

NK460

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 28, 2016

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

-

Product Code

LWJ

Product Code Name

Prosthesis, hip, semi-constrained, metal/polymer, uncemented

Public Device Record Key

d66e141f-f080-4ecc-8fcc-895df04f5df7

Public Version Date

September 09, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-