Catalog Number

-

Brand Name

DJO SURGICAL

Version/Model Number

509-02-036

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

K172351

Product Code

HSD

Product Code Name

PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Public Device Record Key

7374c79f-d90e-4bf1-a29c-e69f227c55b4

Public Version Date

October 09, 2018

Public Version Number

4

DI Record Publish Date

December 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-