Catalog Number

8W15-3523-W

Brand Name

WristMotion® Wrist Hemiarthroplasty System

Version/Model Number

8W15-3523-W

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

K141920

Product Code

KWN

Product Code Name

Prosthesis, Wrist, Carpal Lunate

Public Device Record Key

8fb4f71b-d4f7-4936-a530-709ba7569ec5

Public Version Date

April 08, 2020

Public Version Number

1

DI Record Publish Date

March 31, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-