Catalog Number

105-0028

Brand Name

Glenoid Baseplate with Screw

Version/Model Number

105-0028

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

K192799

Product Code

HSD

Product Code Name

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Public Device Record Key

97931a45-24af-4555-a2d5-a334744e3b0a

Public Version Date

October 07, 2021

Public Version Number

2

DI Record Publish Date

June 25, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-