Home GUDID M268PYROLUNINSTP1 Integra®
Primary DI M268PYROLUNINSTP1
Brand Integra®
Company Ascension Orthopedics, Inc.
Model PYROLUNINSTP
Device description The Integra Lunate system is intended for replacement of the lunate bone in the proximal carpal row of the wrist. The set includes five trials to evaluate the size and fit of the implant. Five sizing templates are also included to assess coverage and establish proper sizing for the component.
Published 2016-08-15
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false 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 10381780235040 Primary GS1 0 M268PYROLUNINSTP1 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10381780235040 10381780235040
GMDN Terms# Term, Definition table Term Definition General external orthopaedic fixation system implantation kit, reusable A collection of mostly instruments intended to be used to manipulate and prepare soft-tissue and bone for the adjustment or placement of the implantable components of an external orthopaedic fixation system in various skeletal areas (e.g., bones of limbs, spine, pelvis, craniomaxillofacial areas). It is a non-dedicated device that includes various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, cutters, screwdrivers, guides, tighteners) that are specific to the fixation system applied; the implant(s) is not included. This is a reusable device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 942377524 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch false Serial number true Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use 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
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