Home GUDID B030EZO1020150 Enza-O
Primary DI B030EZO1020150
Brand Enza-O
Company CAMBER SPINE TECHNOLOGIES, LLC
Model EZO-102-015
Device description ENZA®-O Trial 30mm x 38mm, 15° Lordotic, 11mm
Published 2024-07-18
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B030EZO1020150 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Spinal implant trial A copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 054205979 Device count 1 Premarket exempt true 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 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
Other Devices Sharing Product Codes# 
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