Home GUDID 00840019911368 ShurFit Interbody Device
Primary DI 00840019911368
Brand ShurFit Interbody Device
Company PRECISION SPINE, INC.
Model 26-220805-09
Catalog number 26-220805-09
Device description Narrow PLIF Cage Peek 5 degree 22 x 8 X 9
Published 2019-04-24
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 KWQ Appliance, Fixation, Spinal Intervertebral Body MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic 2 MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840019911368 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 00840019911368 00840019911368 840019911368 0840019911368
GMDN Terms# Term, Definition table Term Definition Polymeric 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 non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] 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 079398589 Device count 1 DM exempt true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00840019904650 Slimplicity Anterior Cervical Plate System ACP118 ACP118 2019-04-11 00840019904667 Slimplicity Anterior Cervical Plate System ACP120 ACP120 2019-04-11 00840019904674 Slimplicity Anterior Cervical Plate System ACP122 ACP122 2019-04-11 00840019904681 Slimplicity Anterior Cervical Plate System ACP124 ACP124 2019-04-11 00840019904698 Slimplicity Anterior Cervical Plate System ACP126 ACP126 2019-04-11 00840019904704 Slimplicity Anterior Cervical Plate System ACP128 ACP128 2019-04-11 00815362021446 Slimplicity Anterior Cervical Plate System 08-9020 08-9020 2019-04-01 00815362021453 Slimplicity Anterior Cervical Plate System 08-9021 08-9021 2019-04-01 00815362021460 Slimplicity Anterior Cervical Plate System 08-9024 08-9024 2019-04-01 00815362021477 Slimplicity Anterior Cervical Plate System 08-9025 08-9025 2019-04-01 00815362021484 Slimplicity Anterior Cervical Plate System 08-9026 08-9026 2019-04-01 00815362021729 Slimplicity Anterior Cervical Plate System 50-0018 50-0018 2019-04-01 00815362021088 Slimplicity Anterior Cervical Plate System 08-0112 08-0112 2019-03-29 00815362021118 Slimplicity Anterior Cervical Plate System 08-0118 08-0118 2019-03-29 00815362021125 Slimplicity Anterior Cervical Plate System 08-0120 08-0120 2019-03-29 00815362021132 Slimplicity Anterior Cervical Plate System 08-0122 08-0122 2019-03-29 00815362021149 Slimplicity Anterior Cervical Plate System 08-0124 08-0124 2019-03-29 00815362021156 Slimplicity Anterior Cervical Plate System 08-0126 08-0126 2019-03-29 00815362021163 Slimplicity Anterior Cervical Plate System 08-0128 08-0128 2019-03-29 00815362021170 Slimplicity Anterior Cervical Plate System 08-0226 08-0226 2019-03-29
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