Catalog Number

-

Brand Name

DJO SURGICAL

Version/Model Number

494-00-058

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K002941

Product Code

LWJ

Product Code Name

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

Public Device Record Key

c85fa6ce-2045-4ef4-916a-72d4c7170225

Public Version Date

September 09, 2020

Public Version Number

4

DI Record Publish Date

October 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-