Catalog Number

650-1061

Brand Name

BIOLOX® OPTION Head System

Version/Model Number

650-1061

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

K082996

Product Code

LZO

Product Code Name

Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Public Device Record Key

8faadf8e-0c09-4622-875f-ad6669b79c57

Public Version Date

December 14, 2018

Public Version Number

1

DI Record Publish Date

November 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-