Home GUDID 00819824020589 AUDERE POSTERIOR LUMBAR SPACER SYSTEM
Primary DI 00819824020589
Brand AUDERE POSTERIOR LUMBAR SPACER SYSTEM
Company MET 1 TECHNOLOGIES, LLC
Model 30290105
Catalog number 30290105
Device description THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AUDERE LUMBAR SPACER SYSTEM MAY BE IMPLANTED BILATERALLY USING A POSTERIOR (PLIF) APPROACH, OR A SINGLE DEVICE EMPLOYING A TRANSFORAMINAL (TLIF) APPROACH.
Published 2017-09-08
Public version status Update
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 00819824020589 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 00819824020589 00819824020589 819824020589 0819824020589
GMDN Terms# Term, Definition table Term Definition Ceramic 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 a ceramic material [e.g., silicon nitride] 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.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 080474650 Device count 1 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 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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