Home GUDID B648C25213000 Prodigy Pedicle Screw System
Primary DI B648C25213000
Brand Prodigy Pedicle Screw System
Company CURITEVA, INC.
Model C525-1300
Device description MIS Tulip Positioner / Rod Pusher
Published 2026-01-08
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 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 B648C25213000 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthopaedic rod reducer A heavy-duty, hand-held manual surgical instrument intended to be used to reduce or seat an implantable rod into the saddle of an implant (i.e., bone screw, spinal hook) used as a component of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. When the rod lies medial or lateral to the implant channel this instrument allows for controlled translation of the rod into the saddle of the screws and/or hooks. The surgeon is able to control the positioning (bending) of the rod into the saddle. Once the rod is securely seated in the saddle it is locked into position with a plug or a setscrew. This is a reusable device.
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 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 B648C2851000 Inspire Lumbar Interbody Fusion System C285-100 2026-01-08 B648C2852000 Inspire Lumbar Interbody Fusion System C285-200 2026-01-08 B648C2951200090 Savant Lumbar Interbody Fusion System C295-1200-09 2026-01-08 B648C2951200100 Savant Lumbar Interbody Fusion System C295-1200-10 2026-01-08 B648C2951200110 Savant Lumbar Interbody Fusion System C295-1200-11 2026-01-08
Other Devices Sharing Product Codes# 
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