Catalog Number

804-03-058

Brand Name

Match Point System

Version/Model Number

804-03-058

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

K153602,K153602

Product Code

KWS

Product Code Name

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

Public Device Record Key

38ab055e-2438-4b70-b129-d092b3850b48

Public Version Date

October 31, 2022

Public Version Number

5

DI Record Publish Date

July 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-