WristMotion® Wrist Hemiarthroplasty System 8W15-3517-W

GUDID M5288W153517W0

15mm Capitate Component, 35mm x 17mm, Wrist, CE

ARTHROSURFACE INCORPORATED

Carpal lunate prosthesis
Primary Device IDM5288W153517W0
NIH Device Record Key3fc27cb9-d1f5-4859-b6ef-06ad80d21c37
Commercial Distribution StatusIn Commercial Distribution
Brand NameWristMotion® Wrist Hemiarthroplasty System
Version Model Number8W15-3517-W
Catalog Number8W15-3517-W
Company DUNS144666109
Company NameARTHROSURFACE INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone508-520-3003
Emailcontact@arthrosurface.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM5288W153517W0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWNProsthesis, Wrist, Carpal Lunate

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-08
Device Publish Date2020-03-31

On-Brand Devices [WristMotion® Wrist Hemiarthroplasty System]

M5288W950016W0Taper Post, 7.5mm Dia, Capitate, CE
M5288W153523W015mm Capitate Component, 35mm x 23mm, Wrist, CE
M5288W153517W015mm Capitate Component, 35mm x 17mm, Wrist, CE
M5288W152223W015mm Capitate Component, 22mm x 23mm, Wrist, CE
M5288W152217W015mm Capitate Component, 22mm x 17mm, Wrist, CE
M5288W123517W012mm Capitate Component, 35mm x 17mm, Wrist, CE
M5288W122217W012mm Capitate Component, 22mm x 17mm, Wrist, CE

Trademark Results [WristMotion]

Mark Image

Registration | Serial
Company
Trademark
Application Date
WRISTMOTION
WRISTMOTION
86513724 5551113 Live/Registered
ARTHROSURFACE INCORPORATED
2015-01-26
WRISTMOTION
WRISTMOTION
86513709 5079866 Live/Registered
ARTHROSURFACE INCORPORATED
2015-01-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.