Home GUDID B4369000950 SiCure Sacroiliac Joint Fusion System
Primary DI B4369000950
Brand SiCure Sacroiliac Joint Fusion System
Company ALEVIO, LLC
Model 900.095
Catalog number 900.095
Device description Load Distribution Cap, 9.5mm DIA.
Published 2016-09-24
Public version status Update
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 B4369000950 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile A sterile 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 uncoated metal [e.g., titanium (Ti)], and typically in the form of a cylinder which may be threaded and/or fenestrated. It is typically surgically implanted under fluoroscopic guidance and may include dedicated disposable implantation instruments.
Device Sizes# Type, Value, Unit table Type Value Unit Outer Diameter 9.5 Millimeter
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 080354484 Device count 1 DM exempt true 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 B436900095350 SiCure Sacroiliac Joint Fusion System 900.095.35 900.095.35 2016-09-24 B436900095400 SiCure Sacroiliac Joint Fusion System 900.095.40 900.095.40 2016-09-24 B436900095450 SiCure Sacroiliac Joint Fusion System 900.095.45 900.095.45 2016-09-24 B436900095500 SiCure Sacroiliac Joint Fusion System 900.095.50 900.095.50 2016-09-24 B436900095550 SiCure Sacroiliac Joint Fusion System 900.095.55 900.095.55 2016-09-24 B436900095600 SiCure Sacroiliac Joint Fusion System 900.095.60 900.095.60 2016-09-24 B436900110 SiCure Sacroiliac Joint Fusion System 900.11 900.11 2016-09-24 B43690011350 SiCure Sacroiliac Joint Fusion System 900.11.35 900.11.35 2016-09-24 B43690011400 SiCure Sacroiliac Joint Fusion System 900.11.40 900.11.40 2016-09-24 B43690011450 SiCure Sacroiliac Joint Fusion System 900.11.45 900.11.45 2016-09-24 B43690011500 SiCure Sacroiliac Joint Fusion System 900.11.50 900.11.50 2016-09-24 B43690011550 SiCure Sacroiliac Joint Fusion System 900.11.55 900.11.55 2016-09-24 B43690011600 SiCure Sacroiliac Joint Fusion System 900.11.60 900.11.60 2016-09-24
Other Devices Sharing Product Codes# 
aleviospine.co
aleviospine.com