Home GUDID B030SPL265008160 SPIRA®-L Open Matrix LLIF
Primary DI B030SPL265008160
Brand SPIRA®-L Open Matrix LLIF
Company CAMBER SPINE TECHNOLOGIES, LLC
Model SPL-2650-0816
Device description Bi-Convex, 8° Lordotic, 26 x 50mm, 16mm
Published 2020-04-24
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 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 B030SPL265008160 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.
Device Sizes# Type, Value, Unit table Type Value Unit Depth 26 Millimeter Height 14 Millimeter Width 50 Millimeter
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 054205979 Device count 1 Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B030SPO1530020 VARIANT SPO-153-002 2022-11-25 B030TLP420WR0 Alcantara™ Thoracolumbar Plating TLP-420WR 2025-08-01 B030TLP422WR0 Alcantara™ Thoracolumbar Plating TLP-422WR 2025-08-01 B030TLP424WR0 Alcantara™ Thoracolumbar Plating TLP-424WR 2025-08-01 B030TLP426WR0 Alcantara™ Thoracolumbar Plating TLP-426WR 2025-08-01 B030TLP428WR0 Alcantara™ Thoracolumbar Plating TLP-428WR 2025-08-01 B030TLP430WR0 Alcantara™ Thoracolumbar Plating TLP-430WR 2025-08-01 B030TLP432WR0 Alcantara™ Thoracolumbar Plating TLP-432WR 2025-08-01 B030TLP434WR0 Alcantara™ Thoracolumbar Plating TLP-434WR 2025-08-01 B030TLP436WR0 Alcantara™ Thoracolumbar Plating TLP-436WR 2025-08-01 B030TLP438WR0 Alcantara™ Thoracolumbar Plating TLP-438WR 2025-08-01 B030TLP440WR0 Alcantara™ Thoracolumbar Plating TLP-440WR 2025-08-01 B030TLP1000 Alcantara Thoracolumbar Plating TLP-100 NA 2024-07-18 B030TLP2180 Alcantara Thoracolumbar Plating TLP-218 NA 2024-07-18 B030TLP2200 Alcantara Thoracolumbar Plating TLP-220 NA 2024-07-18 B030TLP2220 Alcantara Thoracolumbar Plating TLP-222 NA 2024-07-18 B030TLP2240 Alcantara Thoracolumbar Plating TLP-224 NA 2024-07-18 B030TLP2260 Alcantara Thoracolumbar Plating TLP-226 NA 2024-07-18 B030TLP2280 Alcantara Thoracolumbar Plating TLP-228 NA 2024-07-18 B030TLP2350 Alcantara Thoracolumbar Plating TLP-235 NA 2024-07-18
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