Catalog Number

225501003

Brand Name

TruMatch Personalised Solutions Shoulder System

Version/Model Number

225501003

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 05, 2022

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

K172054

Product Code

KWS

Product Code Name

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

Public Device Record Key

7df9cf65-cba6-46dc-a7c5-c0f0a1bbf658

Public Version Date

October 17, 2022

Public Version Number

4

DI Record Publish Date

May 14, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-