Home GUDID M268WRISTFUSESET0 Integra® Total Wrist Fusion System
Primary DI M268WRISTFUSESET0
Brand Integra® Total Wrist Fusion System
Company INTEGRA LIFESCIENCES CORPORATION
Model WRISTFUSESET
Catalog number WRISTFUSESET
Device description The Total Wrist Fusion System (WRISTFUSEEST) consists of two pre-contoured plates with eight holes and a straight plate with nine holes. These plates are fixed to the bone with 2.7mm diameter and 3.5mm diameter screws. Instrumentation is provided to assist in the implantation. Screws with a diameter of 2.7mm vary in size length from 10mm to 24mm. Screws with a diameter of 3.5mm vary in size length from 12mm to 28mm. This system is generally indicated for use in patients with arthritis of the joints of the wrist, rheumatoid wrist deformities, carpal instability, wrist pain, brachial plexus nerve palsies, and loss of function due to osteoarthritis.
Published 2015-08-15
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 LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10381780064350 Primary GS1 0 M268WRISTFUSESET0 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10381780064350 10381780064350
GMDN Terms# Term, Definition table Term Definition Orthopaedic fixation plate, non-bioabsorbable A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.
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 963856096 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 08800089416585 INLET System Bone Screw Jeil Medical Corporation LXT 2021-11-18 08800089416592 INLET System Bone Screw Jeil Medical Corporation LXT 2021-11-18 08800089416608 INLET System Bone Screw Jeil Medical Corporation LXT 2021-11-18 08800089416615 INLET System Bone Screw Jeil Medical Corporation LXT 2021-11-18 08800089416622 INLET System Bone Screw Jeil Medical Corporation LXT 2021-11-18 08800089416639 INLET System Bone Screw Jeil Medical Corporation LXT 2021-11-18 08800089416646 INLET System Bone Screw Jeil Medical Corporation LXT 2021-11-18 08800089416653 INLET System Bone Screw Jeil Medical Corporation LXT 2021-11-18 08800089416660 INLET System Bone Screw Jeil Medical Corporation LXT 2021-11-18 08800089416677 INLET System Bone Screw Jeil Medical Corporation LXT 2021-11-18 08800089416684 INLET System Bone Screw Jeil Medical Corporation LXT 2021-11-18 10381780065197 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065203 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065210 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065227 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065234 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065241 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065258 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065265 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065272 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065289 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065296 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065302 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065319 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065326 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065333 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065340 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065357 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065364 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065371 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09
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