Home GUDID B648C5258001 Prodigy Pedicle Screw System
Primary DI B648C5258001
Brand Prodigy Pedicle Screw System
Company CURITEVA, INC.
Model C525-800
Device description T-Handle Jamshidi Needle 11G x 6
Published 2024-01-05
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile 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 B648C5258001 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Surgical instrument handle, non-torque-limiting A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 6 Inch Needle Gauge 11 Gauge
Regulatory Flags# DUNS number 074575332 Device count 1 Lot or batch true Expiration date on label 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 B648C25213000 Prodigy Pedicle Screw System C525-1300 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
Other Devices Sharing Product Codes# 
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