Home GUDID B515RSTT47555250 Swedge Pedicle Screw Fixation System
Primary DI B515RSTT47555250
Brand Swedge Pedicle Screw Fixation System
Company SPINAL RESOURCES, INC.
Model RSTT47555-250
Device description Rod, Straight, Transition, Titanium, 4.75, 5.00, 5.50mm x 250mm
Published 2024-06-12
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 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 B515RSTT47555250 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthopaedic bone screw (non-sliding) A small, threaded, non-bioabsorbable, implantable rod intended to be used for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, or used in dentistry/orthodontics, craniofacial or spinal bones. It is typically of cortical or cancellous design and has a drive (e.g., a slot, or of cross, star, or polygonal shape) at its proximal end for introduction with a screwdriver. It is made of non-bioabsorbable materials (e.g., metal).
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 018255727 Device count 1 Lot or batch true Manufacturing date on label 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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