Home GUDID 00819824029247
11x32x0° KODIAK TLIF TRIAL
Primary DI 00819824029247
Brand 11x32x0° KODIAK TLIF TRIAL
Company MET 1 TECHNOLOGIES, LLC
Model 04-3211T0
Catalog number 04-3211T0
Device description The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. The Kodiak Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transformational (TLIF) approach. The implants have a central endplate window to permit packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces, and lateral windows for radiographic visualization. The implants are additively manufactured from Ti-6Al-4V ELI and are available in a variety of heights, footprints, and lordotic configurations to suit individual patient anatomy.
Published 2023-09-29
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 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 00819824029247 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00819824029247 00819824029247 819824029247 0819824029247
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 080474650 Device count 1 Lot or batch true Serial number 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 00819824024129 CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL 60010012 60010012 2019-03-06 00819824024136 CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL 60010014 60010014 2019-03-06 00819824024143 CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL 60010016 60010016 2019-03-06 00819824024150 CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL 60010018 60010018 2019-03-06 00819824024167 CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL 60010020 60010020 2019-03-06 00819824024174 CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL 60010022 60010022 2019-03-06 00819824024181 CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL 60010024 60010024 2019-03-06 00819824024198 CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL 60020024 60020024 2019-03-06 00819824024204 CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL 60020026 60020026 2019-03-06 00819824024211 CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL 60020028 60020028 2019-03-06 00819824024228 CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL 60020030 60020030 2019-03-06 00819824024235 CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL 60020032 60020032 2019-03-06 00819824024242 CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL 60020034 60020034 2019-03-06 00819824024259 CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL 60020037 60020037 2019-03-06 00819824024266 CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL 60020040 60020040 2019-03-06 00819824024273 CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL 60020043 60020043 2019-03-06 00819824024280 CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL 60020046 60020046 2019-03-06 00819824024297 CZAR ANTERIOR CERVICAL PLATE SYSTEM 3 LEVEL 60030039 60030039 2019-03-06 00819824024303 CZAR ANTERIOR CERVICAL PLATE SYSTEM 3 LEVEL 60030042 60030042 2019-03-06 00819824024310 CZAR ANTERIOR CERVICAL PLATE SYSTEM 3 LEVEL 60030045 60030045 2019-03-06
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