Home GUDID 00850001740821 Fortuna MIS eX-TAB Stabilization System
Primary DI 00850001740821
Brand Fortuna MIS eX-TAB Stabilization System
Company OSSO SURGICAL LLC
Model 211-003-55140
Device description 5.5mm x 140mm Pre-Lordosed Rod, Bulleted
Published 2021-06-23
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 MNH Orthosis, Spondylolisthesis Spinal Fixation MNI Orthosis, Spinal Pedicle Fixation NKB Thoracolumbosacral Pedicle Screw System OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic 2 MNI Orthosis, Spinal Pedicle Fixation Orthopedic 2 NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2 OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850001740821 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 00850001740821 00850001740821 850001740821 0850001740821
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system, non-sterile An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 081363044 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 00850001740777 Fortuna MIS eX-TAB Stabilization System 211-003-55110 2021-04-23 00850001740784 Fortuna MIS eX-TAB Stabilization System 211-45035-1 2021-04-23 00850001740791 Fortuna MIS eX-TAB Stabilization System 211-45040-1 2021-04-23 00850001740807 Fortuna MIS eX-TAB Stabilization System 211-45045-1 2021-04-23 00850001740814 Fortuna MIS eX-TAB Stabilization System 211-45050-1 2021-04-23 00850001740364 Fortuna MIS eX-TAB Stabilization System 211-55030-1 2020-09-16 00850001740371 Fortuna MIS eX-TAB Stabilization System 211-55035-1 2020-09-16 00850001740388 Fortuna MIS eX-TAB Stabilization System 211-55040-1 2020-09-16 00850001740395 Fortuna MIS eX-TAB Stabilization System 211-55045-1 2020-09-16 00850001740401 Fortuna MIS eX-TAB Stabilization System 211-55050-1 2020-09-16 00850001740418 Fortuna MIS eX-TAB Stabilization System 211-55055-1 2020-09-16 00850001740425 Fortuna MIS eX-TAB Stabilization System 211-65030-1 2020-09-16 00850001740432 Fortuna MIS eX-TAB Stabilization System 211-65035-1 2020-09-16 00850001740449 Fortuna MIS eX-TAB Stabilization System 211-65040-1 2020-09-16 00850001740456 Fortuna MIS eX-TAB Stabilization System 211-65045-1 2020-09-16 00850001740463 Fortuna MIS eX-TAB Stabilization System 211-65050-1 2020-09-16 00850001740470 Fortuna MIS eX-TAB Stabilization System 211-65055-1 2020-09-16 00850001740487 Fortuna MIS eX-TAB Stabilization System 211-75030-1 2020-09-16 00850001740494 Fortuna MIS eX-TAB Stabilization System 211-75035-1 2020-09-16 00850001740500 Fortuna MIS eX-TAB Stabilization System 211-75040-1 2020-09-16
Other Devices Sharing Product Codes#