Home GUDID M9935011250 GSO GS1 Spinal System
Primary DI M9935011250
Brand GSO GS1 Spinal System
Company UNIFIED SPINE, LLC
Model 501125
Device description Set Screw for 5mm Rod System
Published 2016-07-08
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 HWC Screw, Fixation, Bone KWP Appliance, Fixation, Spinal Interlaminal MNH Orthosis, Spondylolisthesis Spinal Fixation MNI Orthosis, Spinal Pedicle Fixation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HWC Screw, Fixation, Bone Orthopedic 2 KWP Appliance, Fixation, Spinal Interlaminal 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 M9935011250 Primary HIBCC 0
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.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 118413370 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 M9935042050 GSO GS1 Spinal System 504205 2018-09-21 M9935042180 GSO GS1 Spinal System 504218 2018-09-21 M9935042190 GSO GS1 Spinal System 504219 2018-09-21 M9935071650 GSO PCT Spinal System 507165 2018-09-21 M9935071760 GSO PCT Spinal System 507176 2018-09-21 M9935071770 GSO PCT Spinal System 507177 2018-09-21 M9935091200 GSO ACP1 Anterior Cervical Plate System 509120 2016-09-14 M9935091220 GSO ACP1 Anterior Cervical Plate System 509122 2016-09-14 M9935091240 GSO ACP1 Anterior Cervical Plate System 509124 2016-09-14 M9935091260 GSO ACP1 Anterior Cervical Plate System 509126 2016-09-14 M9935091280 GSO ACP1 Anterior Cervical Plate System 509128 2016-09-14 M9935091300 GSO ACP1 Anterior Cervical Plate System 509130 2016-09-15 M9935091320 GSO ACP1 Anterior Cervical Plate System 509132 2016-09-14 M9935092340 GSO ACP1 Anterior Cervical Plate System 509234 2016-09-15 M9935092370 GSO ACP1 Anterior Cervical Plate System 509237 2016-09-15 M9935092400 GSO ACP1 Anterior Cervical Plate System 509240 2016-09-15 M9935092430 GSO ACP1 Anterior Cervical Plate System 509243 2016-09-15 M9935092460 GSO ACP1 Anterior Cervical Plate System 509246 2016-09-15 M9935092490 GSO ACP1 Anterior Cervical Plate System 509249 2016-09-15 M9935092520 GSO ACP1 Anterior Cervical Plate System 509252 2016-09-15
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