Home GUDID M824U662251 APEX Spine System
Primary DI M824U662251
Brand APEX Spine System
Company SPINECRAFT, LLC
Model U6-6225
Device description Uniplanar Pedicle Screw, 6.25mm x 25mm
Published 2014-09-24
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name KWP APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWQ APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY MNH Orthosis, spondylolisthesis spinal fixation MNI ORTHOSIS, SPINAL PEDICLE FIXATION NKB Orthosis, spinal pedicle fixation, for degenerative disc disease
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWP Appliance, Fixation, Spinal Interlaminal Orthopedic 2 KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic 2 MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic 2 MNI Orthosis, Spinal Pedicle Fixation Orthopedic 2 NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M824U662251 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Spinal bone screw, non-bioabsorbable A small, threaded, implantable rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 783908713 Device count 1 Lot or batch true No natural rubber latex true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00193082162084 ANTERIS Thoracolumbar Plate System LPS-APSD-10 LPS-APSD-10 2026-05-20 00193082162091 ANTERIS Thoracolumbar Plate System LPS-APSD-12 LPS-APSD-12 2026-05-20 00193082162107 ANTERIS Thoracolumbar Plate System LPS-APSD-14 LPS-APSD-14 2026-05-20 00193082162114 ANTERIS Thoracolumbar Plate System LPS-APSD-16 LPS-APSD-16 2026-05-20 00193082162121 ANTERIS Thoracolumbar Plate System LPS-APSD-18 LPS-APSD-18 2026-05-20 00193082162138 ANTERIS Thoracolumbar Plate System LPS-APSD-20 LPS-APSD-20 2026-05-20 00193082162145 ANTERIS Thoracolumbar Plate System LPS-APSD-22 LPS-APSD-22 2026-05-20 00193082162152 ANTERIS Thoracolumbar Plate System LPS-APSD-24 LPS-APSD-24 2026-05-20 00193082162169 ANTERIS Thoracolumbar Plate System LPS-APSL-10 LPS-APSL-10 2026-05-20 00193082162176 ANTERIS Thoracolumbar Plate System LPS-APSL-12 LPS-APSL-12 2026-05-20 00193082162183 ANTERIS Thoracolumbar Plate System LPS-APSL-14 LPS-APSL-14 2026-05-20 00193082162190 ANTERIS Thoracolumbar Plate System LPS-APSL-16 LPS-APSL-16 2026-05-20 00193082162206 ANTERIS Thoracolumbar Plate System LPS-APSL-18 LPS-APSL-18 2026-05-20 00193082162213 ANTERIS Thoracolumbar Plate System LPS-APSL-20 LPS-APSL-20 2026-05-20 00193082162220 ANTERIS Thoracolumbar Plate System LPS-APSL-22 LPS-APSL-22 2026-05-20 00193082162237 ANTERIS Thoracolumbar Plate System LPS-APSL-24 LPS-APSL-24 2026-05-20 00193082162688 ANTERIS Thoracolumbar Plate System LPS-APS50-30 LPS-APS50-30 2026-05-20 00193082162695 ANTERIS Thoracolumbar Plate System LPS-APS55-30 LPS-APS55-30 2026-05-20 00193082162701 ANTERIS Thoracolumbar Plate System LPS-APS50-20 LPS-APS50-20 2026-05-20 00193082162718 ANTERIS Thoracolumbar Plate System LPS-APS55-20 LPS-APS55-20 2026-05-20
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