Home GUDID B521115003540 Apollo Anterior Cervical Plate System
Primary DI B521115003540
Brand Apollo Anterior Cervical Plate System
Company AURORA SPINE, INC.
Model 115-003-54
Device description Apollo Plate 3 Level 54mm
Published 2024-08-13
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 B521115003540 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; 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). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 079119091 Device count 1 Lot or batch true No natural rubber latex true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B521115001100 Apollo Anterior Cervical Plate System 115-001-10 2024-08-13 B521115001120 Apollo Anterior Cervical Plate System 115-001-12 2024-08-13 B521115001140 Apollo Anterior Cervical Plate System 115-001-14 2024-08-13 B521115001160 Apollo Anterior Cervical Plate System 115-001-16 2024-08-13 B521115001180 Apollo Anterior Cervical Plate System 115-001-18 2024-08-13 B521115001200 Apollo Anterior Cervical Plate System 115-001-20 2024-08-13 B521115001220 Apollo Anterior Cervical Plate System 115-001-22 2024-08-13 B521115001240 Apollo Anterior Cervical Plate System 115-001-24 2024-08-13 B521115001260 Apollo Anterior Cervical Plate System 115-001-26 2024-08-13 B521115002260 Apollo Anterior Cervical Plate System 115-002-26 2024-08-13 B521115002280 Apollo Anterior Cervical Plate System 115-002-28 2024-08-13 B521115002300 Apollo Anterior Cervical Plate System 115-002-30 2024-08-13 B521115002320 Apollo Anterior Cervical Plate System 115-002-32 2024-08-13 B521115002340 Apollo Anterior Cervical Plate System 115-002-34 2024-08-13 B521115002360 Apollo Anterior Cervical Plate System 115-002-36 2024-08-13 B521115002380 Apollo Anterior Cervical Plate System 115-002-38 2024-08-13 B521115002400 Apollo Anterior Cervical Plate System 115-002-40 2024-08-13 B521115002420 Apollo Anterior Cervical Plate System 115-002-42 2024-08-13 B521115003390 Apollo Anterior Cervical Plate System 115-003-39 2024-08-13 B521115003420 Apollo Anterior Cervical Plate System 115-003-42 2024-08-13
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