Home GUDID B5211161416707MD0 DEXA-C CERVICAL INTERBODY SYSTEM
Primary DI B5211161416707MD0
Brand DEXA-C CERVICAL INTERBODY SYSTEM
Company AURORA SPINE, INC.
Model 116-14167-07-MD
Device description Mid Density 14mm x 16mm x 7° x 7mm
Published 2023-07-14
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Sterile true
Single use true Product Codes# Code, Name table Code Name ODP Intervertebral Fusion Device With Bone Graft, Cervical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B5211161416707MD0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Metallic spinal interbody fusion cage A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.
Regulatory Flags# DUNS number 079119091 Device count 1 Lot or batch true Expiration date on label 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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