Home GUDID M364111106FD4900 Asfora Anterior Cervical Plate System
Primary DI M364111106FD4900
Brand Asfora Anterior Cervical Plate System
Company MEDICAL DESIGNS LLC
Model 11-1106-FD4-90
Device description 4 Level, 90mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporarystabilization to the anterior spine during the development of cervical spinefusions (C2-T1) for the following indications: degenerative disc disease (DDD)(defined as neck pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies), spondylolisthesis, trauma (i.e.,fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis,kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Published 2016-09-27
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true
Product Codes# Code, Name table Code Name KWQ Appliance, Fixation, Spinal Intervertebral Body
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 111106490 Direct Marking HIBCC 0 M364111106FD4900 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Spinal fixation plate, non-bioabsorbable A small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 003815548 Device count 1 Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M364111106FD1220 Asfora Anterior Cervical Plate System 11-1106-FD1-22 2016-09-27 M364111106FD1240 Asfora Anterior Cervical Plate System 11-1106-FD1-24 2016-09-27 M364111106FD1260 Asfora Anterior Cervical Plate System 11-1106-FD1-26 2016-09-27 M364111106FD1280 Asfora Anterior Cervical Plate System 11-1106-FD1-28 2016-09-27 M364111106FD1300 Asfora Anterior Cervical Plate System 11-1106-FD1-30 2016-09-27 M364111106FD1320 Asfora Anterior Cervical Plate System 11-1106-FD1-32 2016-09-27 M364111106FD1340 Asfora Anterior Cervical Plate System 11-1106-FD1-34 2016-09-27 M364111106FD2320 Asfora Anterior Cervical Plate System 11-1106-FD2-32 2016-09-27 M364111106FD2350 Asfora Anterior Cervical Plate System 11-1106-FD2-35 2016-09-27 M364111106FD2380 Asfora Anterior Cervical Plate System 11-1106-FD2-38 2016-09-27 M364111106FD2410 Asfora Anterior Cervical Plate System 11-1106-FD2-41 2016-09-27 M364111106FD2440 Asfora Anterior Cervical Plate System 11-1106-FD2-44 2016-09-27 M364111106FD2470 Asfora Anterior Cervical Plate System 11-1106-FD2-47 2016-09-27 M364111106FD2500 Asfora Anterior Cervical Plate System 11-1106-FD2-50 2016-09-27 M364111106FD350 Asfora Anterior Cervical Plate System 11-1106-FD35 2016-09-27 M364111106FD3510 Asfora Anterior Cervical Plate System 11-1106-FD3-51 2016-09-27 M364111106FD3540 Asfora Anterior Cervical Plate System 11-1106-FD3-54 2016-09-27 M364111106FD3570 Asfora Anterior Cervical Plate System 11-1106-FD3-57 2016-09-27 M364111106FD3600 Asfora Anterior Cervical Plate System 11-1106-FD3-60 2016-09-27 M364111106FD3630 Asfora Anterior Cervical Plate System 11-1106-FD3-63 2016-09-27
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