Home GUDID 08800017226552 LOSPA IS Spinal System
Primary DI 08800017226552
Brand LOSPA IS Spinal System
Company Corentec Co., Ltd
Model 01.27.616
Device description Pedicle screw(Guided, Blasting)
Published 2017-12-26
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 KWQ Appliance, Fixation, Spinal Intervertebral Body MNH Orthosis, Spondylolisthesis Spinal Fixation MNI Orthosis, Spinal Pedicle Fixation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic 2 MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic 2 MNI Orthosis, Spinal Pedicle Fixation Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08800017226552 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800017226552 08800017226552 8800017226552
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 688739895 Device count 1 Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 08800017262178 EXULT Knee Replacement System K3.IAX.4469-09T 2020-01-10 08800017262185 EXULT Knee Replacement System K3.IAX.4469-10T 2020-01-10 08800017262192 EXULT Knee Replacement System K3.IAX.4469-11T 2020-01-10 08800017262208 EXULT Knee Replacement System K3.IAX.4469-12T 2020-01-10 08800017262215 EXULT Knee Replacement System K3.IAX.4469-13T 2020-01-10 08800017262222 EXULT Knee Replacement System K3.IAX.4469-14T 2020-01-10 08800017262239 EXULT Knee Replacement System K3.IAX.4469-16T 2020-01-10 08800017262246 EXULT Knee Replacement System K3.IAX.4469-18T 2020-01-10 08800017262253 EXULT Knee Replacement System K3.IAX.4572-09T 2020-01-10 08800017262260 EXULT Knee Replacement System K3.IAX.4572-10T 2020-01-10 08800017262277 EXULT Knee Replacement System K3.IAX.4572-11T 2020-01-10 08800017262284 EXULT Knee Replacement System K3.IAX.4572-12T 2020-01-10 08800017262291 EXULT Knee Replacement System K3.IAX.4572-13T 2020-01-10 08800017262307 EXULT Knee Replacement System K3.IAX.4572-14T 2020-01-10 08800017262314 EXULT Knee Replacement System K3.IAX.4572-16T 2020-01-10 08800017262321 EXULT Knee Replacement System K3.IAX.4572-18T 2020-01-10 08800017262338 EXULT Knee Replacement System K3.IAX.4775-09T 2020-01-10 08800017262345 EXULT Knee Replacement System K3.IAX.4775-10T 2020-01-10 08800017262352 EXULT Knee Replacement System K3.IAX.4775-11T 2020-01-10 08800017262369 EXULT Knee Replacement System K3.IAX.4775-12T 2020-01-10
Other Devices Sharing Product Codes# 
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