Home GUDID B52111400445200 SiLO TFX MIS Sacroiliac Joint Fixation System
Primary DI B52111400445200
Brand SiLO TFX MIS Sacroiliac Joint Fixation System
Company AURORA SPINE, INC.
Model 114-004-4520
Device description SiLO TFX Sacrum Screw Ø4.5mm x 20mm
Published 2024-08-13
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name OUR Sacroiliac Joint Fixation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OUR Sacroiliac Joint Fixation Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B52111400445200 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Sacroiliac joint transarticular fixation/arthrodesis implant, coated An implantable device designed to be inserted across the sacroiliac joint to provide temporary stabilization and to encourage long-term joint fusion, typically to alleviate pain from the joint. It is made of metal [e.g., titanium (Ti)] with a porous plasma spray coating, and typically in the form of a cylinder or rod, possibly with a triangular cross-section. It is typically surgically implanted under fluoroscopic guidance and may include dedicated disposable implantation instruments.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 079119091 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 B521115001100 Apollo Anterior Cervical Plate System 115-001-10 2024-08-13 B521115001120 Apollo Anterior Cervical Plate System 115-001-12 2024-08-13 B521115001140 Apollo Anterior Cervical Plate System 115-001-14 2024-08-13 B521115001160 Apollo Anterior Cervical Plate System 115-001-16 2024-08-13 B521115001180 Apollo Anterior Cervical Plate System 115-001-18 2024-08-13 B521115001200 Apollo Anterior Cervical Plate System 115-001-20 2024-08-13 B521115001220 Apollo Anterior Cervical Plate System 115-001-22 2024-08-13 B521115001240 Apollo Anterior Cervical Plate System 115-001-24 2024-08-13 B521115001260 Apollo Anterior Cervical Plate System 115-001-26 2024-08-13 B521115002260 Apollo Anterior Cervical Plate System 115-002-26 2024-08-13 B521115002280 Apollo Anterior Cervical Plate System 115-002-28 2024-08-13 B521115002300 Apollo Anterior Cervical Plate System 115-002-30 2024-08-13 B521115002320 Apollo Anterior Cervical Plate System 115-002-32 2024-08-13 B521115002340 Apollo Anterior Cervical Plate System 115-002-34 2024-08-13 B521115002360 Apollo Anterior Cervical Plate System 115-002-36 2024-08-13 B521115002380 Apollo Anterior Cervical Plate System 115-002-38 2024-08-13 B521115002400 Apollo Anterior Cervical Plate System 115-002-40 2024-08-13 B521115002420 Apollo Anterior Cervical Plate System 115-002-42 2024-08-13 B521115003390 Apollo Anterior Cervical Plate System 115-003-39 2024-08-13 B521115003420 Apollo Anterior Cervical Plate System 115-003-42 2024-08-13
Other Devices Sharing Product Codes# 
auroraspine.us