Home GUDID B648C504R55PB0 Prodigy Pedicle Screw System
Primary DI B648C504R55PB0
Brand Prodigy Pedicle Screw System
Company CURITEVA, INC.
Model C504-R55-PB
Device description Prodigy, 5.5 x 500mm PRE- BENT ROD, TITANIUM
Published 2025-08-07
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 NKB Thoracolumbosacral Pedicle Screw System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWP Appliance, Fixation, Spinal Interlaminal Orthopedic 2 NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B648C504R55PB0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system sterilization container/implant set A collection of non-sterile, implantable components of a bone-screw internal spinal fixation system (e.g., rods, screws, connectors, hooks) supplied within a reusable sterilization container (i.e., all under the same product code) to be sterilized before they are implanted as part of an internal spinal fixation procedure. The set provides the surgeon with a selection of implants (e.g., different sizes) during surgery, whereby unused implants maybe resterilised for subsequent implantation in another patient. This is a reusable device which includes single-use implants.
Device Sizes# Type, Value, Unit table Type Value Unit Length 500 Millimeter Outer Diameter 5.5 Millimeter
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 074575332 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 B648C284302412121 Inspire Lumbar Interbody Fusion System C284-302412-12 2026-07-06 B648C284302412141 Inspire Lumbar Interbody Fusion System C284-302414-12 2026-07-06 B648C284302412161 Inspire Lumbar Interbody Fusion System C284-302416-12 2026-07-06 B648C28430241861 Inspire Lumbar Interbody Fusion System C284-302418-6 2026-07-06 B648C29515000 Savant Lumbar Interbody Fusion System C295-1500 2026-07-06 B648C4452100 Savant Lumbar Interbody Fusion System C445-210 2024-01-04 B648C4452200 Savant Lumbar Interbody Fusion System C445-220 2024-01-04 B648C2853000 Inspire Lumbar Interbody Fusion System C285-300 2026-01-09 B648C3051500 Savant Lumbar Interbody Fusion System C305-150 2026-01-09 B648C505420450 Prodigy Pedicle Screw System C505-420-45 2026-01-09 B648C505420550 Prodigy Pedicle Screw System C505-420-55 2026-01-09 B648C505420650 Prodigy Pedicle Screw System C505-420-65 2026-01-09 B648C6151252750 SI-LUTION Sacroiliac Joint Fusion System C615-125-275 2026-01-09 B648C615125275E0 SI-LUTION Sacroiliac Joint Fusion System C615-125-275E 2026-01-09 B648C6151253000 SI-LUTION Sacroiliac Joint Fusion System C615-125-300 2026-01-09 B648C615125300E0 SI-LUTION Sacroiliac Joint Fusion System C615-125-300E 2026-01-09 B648C6151253250 SI-LUTION Sacroiliac Joint Fusion System C615-125-325 2026-01-09 B648C615125325E0 SI-LUTION Sacroiliac Joint Fusion System C615-125-325E 2026-01-09 B648C72540281420T0 Inspire®SA 3D Printed Trabecular PEEK™ with HAFUSE® C725-402814-20T 2026-01-09 B648C11551560 Acumen Thoracolumbar Plate System C1155-156 2026-01-08
Other Devices Sharing Product Codes# 
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