Catalog Number

105-36-16

Brand Name

Ingen SEVIIN® Shoulder System

Version/Model Number

105-36-16

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K120374

Product Code

PHX

Product Code Name

Shoulder Prosthesis, Reverse Configuration

Public Device Record Key

ca67c934-7cfd-414b-bf35-24bd52e051f8

Public Version Date

March 28, 2019

Public Version Number

1

DI Record Publish Date

March 20, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-