Home GUDID B5211120241200110 TiNano
Primary DI B5211120241200110
Brand TiNano
Company AURORA SPINE, INC.
Model ECHO SD
Catalog number 112-02412-0011
Device description ECHO SD Lumbar Interbody Fusion System, 24mm x 12mm x 0 degrees x 11mm
Published 2019-04-01
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B5211120241200110 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Polymeric spinal fusion cage, sterile A sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Disposable devices associated with implantation may be included.
Device Sizes# Type, Value, Unit table Type Value Unit Angle 0 degree Height 11 Millimeter Length 24 Millimeter Width 12 Millimeter
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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