Home GUDID 00810055526413 5.5 mm x 35 mm iFuse Granite Onyx Implant
Primary DI 00810055526413
Brand 5.5 mm x 35 mm iFuse Granite Onyx Implant
Company Si-Bone Inc.
Model 055035BG
Device description 5.5 mm x 35 mm iFuse Granite Onyx Implant
Published 2026-09-30
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name NKB Thoracolumbosacral Pedicle Screw System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810055526413 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00810055526413 00810055526413 810055526413 0810055526413
GMDN Terms# Term, Definition table Term Definition Spinal bone screw, non-bioabsorbable A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.
Device Sizes# Type, Value, Unit table Type Value Unit Length 0 Width 0
Regulatory Flags# DUNS number 830127168 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 false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810055525225 Onyx 4.5 mm Navigated Cannulated Tap 400539-0450 2026-09-30 00810055525232 Onyx 5.5mm Navigated Cannulated Tap 400539-0550 2026-09-30 00810055525249 Onyx 6.5mm Navigated Cannulated Tap 400539-0650 2026-09-30 00810055525256 Onyx 7.5mm Navigated Cannulated Tap 400539-0750 2026-09-30 00810055525263 Onyx 4.5 mm Navigated Awl Tip Tap 400540-0450 2026-09-30 00810055525270 Onyx 5.5 mm Navigated Awl Tip Tap 400540-0550 2026-09-30 00810055525287 Onyx 6.5 mm Navigated Awl Tip Tap 400540-0650 2026-09-30 00810055525294 Onyx 7.5 mm Navigated Awl Tip Tap 400540-0750 2026-09-30 00810055525720 Onyx Navigated Locking Driver 403035-0100 2026-09-30 00810055525966 Onyx Navigated Locking Driver, Cannulated 403035-0200 2026-09-30 00810055526284 Onyx iGPS Awl Tip Tap 4.5mm 503189-0450 2026-09-30 00810055526291 Onyx iGPS Awl Tip Tap 5.5mm 503189-0550 2026-09-30 00810055526307 Onyx iGPS Awl Tip Tap 6.5mm 503189-0650 2026-09-30 00810055526314 Onyx iGPS Awl Tip Tap 7.5mm 503189-0750 2026-09-30 00810055526321 Onyx iGPS Driver 403057 2026-09-30 00810055526390 5.5 mm x 25 mm iFuse Granite Onyx Implant 055025BG 2026-09-30 00810055526406 5.5 mm x 30 mm iFuse Granite Onyx Implant 055030BG 2026-09-30 00810055526420 5.5 mm x 40 mm iFuse Granite Onyx Implant 055040BG 2026-09-30 00810055526437 5.5 mm x 45 mm iFuse Granite Onyx Implant 055045BG 2026-09-30 00810055526444 5.5 mm x 50 mm iFuse Granite Onyx Implant 055050BG 2026-09-30
Other Devices Sharing Product Codes# 
si-bone.com