Home GUDID M5288W153523A0
HemiCAPITATETM
Primary DI M5288W153523A0
Brand HemiCAPITATETM
Company ARTHROSURFACE INCORPORATED
Model 8W15-3523-A
Catalog number 8W15-3523-A
Device description 15mm Capitate Component, 35mm x 23mm, Wrist
Published 2016-07-14
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true
Product Codes# Code, Name table Code Name KWN Prosthesis, Wrist, Carpal Lunate
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWN Prosthesis, Wrist, Carpal Lunate Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M5288W153523A0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Carpal lunate prosthesis A sterile implantable device designed to replace the lunate bone in the proximal carpal row of the wrist typically in the presence of avascular necrosis, localized osteoarthritic changes, or longstanding dislocations. It is typically a one-piece device, made of one or several materials (e.g., carbon, graphite, metal), that may reflect the shape of the native bone. Short-term fixation is typically performed with sutures.
Regulatory Flags# DUNS number 144666109 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00885556858721 PyroCarbon Lunate Smith & Nephew, Inc. KWN 2023-02-10 00885556858738 PyroCarbon Lunate Smith & Nephew, Inc. KWN 2023-02-10 00885556858745 PyroCarbon Lunate Smith & Nephew, Inc. KWN 2023-02-10 00885556858752 PyroCarbon Lunate Smith & Nephew, Inc. KWN 2023-02-10 00885556858769 PyroCarbon Lunate Smith & Nephew, Inc. KWN 2023-02-10 00885556858820 PyroCarbon Lunate Smith & Nephew, Inc. KWN 2023-02-10 00885556858837 PyroCarbon Lunate Smith & Nephew, Inc. KWN 2023-02-10 00885556858844 PyroCarbon Lunate Smith & Nephew, Inc. KWN 2023-02-10 00885556858851 PyroCarbon Lunate Smith & Nephew, Inc. KWN 2023-02-10 00885556858868 PyroCarbon Lunate Smith & Nephew, Inc. KWN 2023-02-10 M5288W122217W0 WristMotion® Wrist Hemiarthroplasty System ARTHROSURFACE INCORPORATED KWN 2020-03-31 M5288W123517W0 WristMotion® Wrist Hemiarthroplasty System ARTHROSURFACE INCORPORATED KWN 2020-03-31 M5288W152217W0 WristMotion® Wrist Hemiarthroplasty System ARTHROSURFACE INCORPORATED KWN 2020-03-31 M5288W152223W0 WristMotion® Wrist Hemiarthroplasty System ARTHROSURFACE INCORPORATED KWN 2020-03-31 M5288W153517W0 WristMotion® Wrist Hemiarthroplasty System ARTHROSURFACE INCORPORATED KWN 2020-03-31 M5288W153523W0 WristMotion® Wrist Hemiarthroplasty System ARTHROSURFACE INCORPORATED KWN 2020-03-31 M5288W950016W0 WristMotion® Wrist Hemiarthroplasty System ARTHROSURFACE INCORPORATED KWN 2020-03-31 M5288W122217A0 HemiCAPITATETM ARTHROSURFACE INCORPORATED KWN 2018-04-16 00887868239830 Maestro™ Total Wrist Biomet Orthopedics, LLC KWN 2018-03-02 00887868239847 Maestro™ Total Wrist Biomet Orthopedics, LLC KWN 2018-03-02 00887868239854 Maestro™ Total Wrist Biomet Orthopedics, LLC KWN 2018-03-02 10381780116240 Ascension® PyroCarbon Lunate Ascension Orthopedics, Inc. KWN 2017-10-09 10381780116257 Ascension® PyroCarbon Lunate Ascension Orthopedics, Inc. KWN 2017-10-09 10381780116264 Ascension® PyroCarbon Lunate Ascension Orthopedics, Inc. KWN 2017-10-09 10381780116271 Ascension® PyroCarbon Lunate Ascension Orthopedics, Inc. KWN 2017-10-09 10381780116288 Ascension® PyroCarbon Lunate Ascension Orthopedics, Inc. KWN 2017-10-09 10381780235040 Integra® Ascension Orthopedics, Inc. KWN 2016-08-15 10381780236795 Integra® Ascension Orthopedics, Inc. KWN 2016-08-15 10381780236801 Integra® Ascension Orthopedics, Inc. KWN 2016-08-15 10381780236818 Integra® Ascension Orthopedics, Inc. KWN 2016-08-15