Home GUDID M824PR64770CF1 APEX Spine System
Primary DI M824PR64770CF1
Brand APEX Spine System
Company SPINECRAFT, LLC
Model PR6-4770C-F
Device description Cannulated Polyaxial Pedicle Reduction Screw 4.75 x 70mm, Self-Tapping
Published 2014-09-24
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 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 M824PR64770CF1 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system An assembly of implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Disposable devices associated with implantation may be included.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 783908713 Device count 1 DM exempt true 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
Other Devices Sharing Product Codes# 
spinecraft.com