Catalog Number

105-0002

Brand Name

Humelock II Cemented Shoulder System

Version/Model Number

105-0002

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

K123814

Product Code

KWT

Product Code Name

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

Public Device Record Key

b38afa39-5860-4be2-82e8-7668ebee4e80

Public Version Date

October 07, 2021

Public Version Number

5

DI Record Publish Date

June 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-