Home GUDID B648C6156200 SI-LUTION Sacroiliac Joint Fusion System
Primary DI B648C6156200
Brand SI-LUTION Sacroiliac Joint Fusion System
Company CURITEVA, INC.
Model C615-620
Device description 12mm DRILL
Published 2024-01-05
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 B648C6156200 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Cannulated surgical drill bit, reusable A shaft of metal intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) to clear a channel of the same dimension as the diameter of the shaft. This drill is cannulated, having a hollow centre, and is typically flexible so that it can be fed over a guiding pin that has been placed into the correct position prior to operation. This device is typically used in orthopaedic surgery for clearing of the intramedullary channel prior to the insertion of a prosthetic device. This is a reusable device.
Device Sizes# Type, Value, Unit table Type Value Unit Outer Diameter 12 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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