Catalog Number

-

Brand Name

DJO SURGICAL

Version/Model Number

495-00-065

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

K161610

Product Code

KWZ

Product Code Name

Prosthesis, hip, constrained, cemented or uncemented, metal/polymer

Public Device Record Key

0a03f763-f129-47ae-b2c0-1a063c3b22dd

Public Version Date

October 12, 2018

Public Version Number

4

DI Record Publish Date

February 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-