Catalog Number

SSI000166

Brand Name

Comprehensive Shoulder System

Version/Model Number

SSI000166

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 04, 2016

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

-

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

K060694

Product Code

KWS

Product Code Name

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

Public Device Record Key

f7ffa853-05e1-4d18-bd8e-2d617f142c7a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 04, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-