Catalog Number

-

Brand Name

DJO SURGICAL

Version/Model Number

495-15-130

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

K163497

Product Code

KWZ

Product Code Name

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

Public Device Record Key

bbd6ec0f-c9cf-4ae0-8ee8-05170631cad1

Public Version Date

October 11, 2018

Public Version Number

4

DI Record Publish Date

March 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-