Catalog Number

-

Brand Name

Shoulder System

Version/Model Number

04.01.0196

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

K181826

Product Code

PHX

Product Code Name

Shoulder Prosthesis, Reverse Configuration

Public Device Record Key

4bd0b993-c34b-4cd3-9f7f-e8eee7baf577

Public Version Date

February 15, 2019

Public Version Number

1

DI Record Publish Date

January 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-