Catalog Number

115-4010

Brand Name

TiN Coated Glenosphere

Version/Model Number

115-4010

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K191146

Product Code

PHX

Product Code Name

Shoulder Prosthesis, Reverse Configuration

Public Device Record Key

bbf8da3e-0947-483b-81c4-77c7824af009

Public Version Date

October 08, 2021

Public Version Number

2

DI Record Publish Date

July 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-