Home GUDID B5152105450 Swedge Pedicle Screw Fixation System
Primary DI B5152105450
Brand Swedge Pedicle Screw Fixation System
Company SPINAL RESOURCES, INC.
Model 2-105-45
Device description Screw Tap, Standard, Solid, 4.5mm x 30mm long
Published 2018-03-12
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 NKB Thoracolumbosacral Pedicle Screw System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B5152105450 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition General internal orthopaedic fixation system implantation kit A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 018255727 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 B515LC020 Locking Cap (Set Screw) LC-02 2026-05-15 B515NCRTT475550060 Swedge Rod, Hyper-Lordotic Curved, Transition NCRTT47555-060 2026-05-15 B515NCRTT475550070 Swedge Rod, Hyper-Lordotic Curved, Transition NCRTT47555-070 2026-05-15 B515NCRTT475550080 Swedge Rod, Hyper-Lordotic Curved, Transition NCRTT47555-080 2026-05-15 B515NCRTT475550090 Swedge Rod, Hyper-Lordotic Curved, Transition NCRTT47555-090 2026-05-15 B515NCRTT475550100 Swedge Rod, Hyper-Lordotic Curved, Transition NCRTT47555-100 2026-05-15 B515RMCT55065 Swedge Rod, MIS, Curved RMCT55-65 2026-05-15 B515RSCT55045 Swedge Rod RSCT55-45 2026-05-15 B515RSCT55050 Swedge Rod RSCT55-50 2026-05-15 B515RSCT600500 Swedge Rod RSCT60-500 2026-05-15 B515RSCTT475550040 Swedge Rod RSCTT47555-040 2026-05-15 B515RSCTT475550045 Swedge Rod RSCTT47555-045 2026-05-15 B515RSCTT475550050 Swedge Rod RSCTT47555-050 2026-05-15 B515RSCTT475550120 Swedge Rod RSCTT47555-120 2026-05-15 B515RSCTT475550150 Swedge Rod RSCTT47555-150 2026-05-15 B515RSCTT475550200 Swedge Rod RSCTT47555-200 2026-05-15 B515RSCTT475550250 Swedge Rod RSCTT47555-250 2026-05-15 B515RSCTT475550300 Swedge Rod RSCTT47555-300 2026-05-15 B515RSCTT50550045 Swedge Rod RSCTT5055-045 2026-05-15 B515RSCTT50550050 Swedge Rod RSCTT5055-050 2026-05-15
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