Home GUDID M9935081550 GSO GS1 Spinal System
Primary DI M9935081550
Brand GSO GS1 Spinal System
Company UNIFIED SPINE, LLC
Model 508155
Device description Set Screw Starter
Published 2018-09-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name LXH Orthopedic Manual Surgical Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M9935081550 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthopaedic bone screw starter/notcher A hand-held surgical instrument used to create an indentation or enlarge a pre-drilled pilot hole in a bone that will enable the surgeon to begin threading a bone screw or place another form of anchoring device. This device, commonly known as a bone notcher, may function and be used in a variety of ways: 1) notch the bone such that the threads on a bone screw will bite into the bone; 2) simply hold the screw at the desired angle to the bone while the screw is driven into position; or 3) in the case of hard bone (e.g., on the glenoid) be inserted into a pilot hole where it is rotated to create a cavity within the soft bone for placement of, e.g., a suture anchor. This is a reusable device.
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 Premarket 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 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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