Catalog Number

116-5019

Brand Name

TiN Coated Humeral Head

Version/Model Number

116-5019

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

K191698

Product Code

KWT

Product Code Name

Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Public Device Record Key

9208f384-089a-4348-8b1a-b78f1cd53a04

Public Version Date

October 08, 2021

Public Version Number

2

DI Record Publish Date

July 21, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-