Home GUDID B648C29515000 Savant Lumbar Interbody Fusion System
Primary DI B648C29515000
Brand Savant Lumbar Interbody Fusion System
Company CURITEVA, INC.
Model C295-1500
Device description B648C29515000
Published 2026-07-06
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B648C29515000 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.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 074575332 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 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
Other Devices Sharing Product Codes# 
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