Home GUDID B515RM3TC47555400 Swedge Pedicle Screw Fixation System
Primary DI B515RM3TC47555400
Brand Swedge Pedicle Screw Fixation System
Company SPINAL RESOURCES, INC.
Model RM3TC47555-400
Device description Rod, Morphotype, Titanium 4.75, 5.00, 5.50mm x 400mm
Published 2024-03-12
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 B515RM3TC47555400 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system, non-sterile An assembly of non-sterile 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. Non-sterile disposable devices associated with implantation may be included.
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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