Home GUDID B515SPSCT6545 Swedge Pedicle Screw Fixation System
Primary DI B515SPSCT6545
Brand Swedge Pedicle Screw Fixation System
Company SPINAL RESOURCES, INC.
Model SPSCT6545
Device description Polyscrew, Standard, Cannulated, Ti, Ø6.5mm x 45mm
Published 2024-07-29
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 B515SPSCT6545 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 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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