Catalog Number

01-03-0039

Brand Name

Biocore9 Femoral Resurfacing Component

Version/Model Number

Femoral Resurfacing Component - 39.5 mm

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

K201219

Product Code

KXA

Product Code Name

Prosthesis, Hip, Femoral, Resurfacing

Public Device Record Key

d5bb79b0-0700-495e-84e8-8a6e76def486

Public Version Date

October 05, 2021

Public Version Number

1

DI Record Publish Date

September 27, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-