GSO GS1 Spinal System

GUDID M9935017651

Multi-Directional Screw

UNIFIED SPINE, LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: M9935017651
• NIH Device Record Key: ba056680-dbf4-4e12-a61c-29bd881e928e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GSO GS1 Spinal System
• Version Model Number: 501765
• Company DUNS: 118413370
• Company Name: UNIFIED SPINE, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

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Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M9935017651 [Primary]

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

[M9935017651]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-07-20
• Device Publish Date: 2015-08-10

On-Brand Devices [GSO GS1 Spinal System]

• M9935041650: Locking Screw Inserter Assembly
• M9935082450: Access Instrument Trocar
• M9935082440: Cannulated Bone Tap With 1/4" Square QC
• M9935082410: T-handle for Access Tool
• M9935082200: Palm Handle Ratchet with 1/4" Square Drive
• M9935082120: Rod Holder Hex Driver
• M9935082080: Compressor Separation Instrument
• M9935082070: Distractor
• M9935082060: 3.5mm Hex Driver w/ Collar
• M9935081550: Set Screw Starter
• M9935081540: 3.5mm Hex Bit - 1/4" Drive for Cannulated Screws
• M9935081530: Anti-Torque Starter
• M9935081520: Anti-Torque Device
• M9935081230: Calipers
• M9935081160: Ring Breaker
• M9935081150: Cannula / Dilator Set
• M9935042220: Straight Probe
• M9935042190: In-Situ Rod Benders, Left
• M9935042180: In-Situ Rod Benders, Right
• M9935042160: Curved Probe
• M9935042150: Bone Probe
• M9935042100: Rod Gripper
• M9935042090: Rod Reducer
• M9935042080: Rod Compressor
• M9935042070: Rod Distractor
• M9935042050: Hand Held Rod Benders
• M9935041720: Hook Grasper
• M9935041610: Multi-Axial Screw Inserter With Nut
• M9935041550: Set Screw Starter
• M9935041540: 3.5mm Hex Bit - 1/4" Drive
• M9935041520: Anti-Torque Device
• M9935041510: Poly-Axial Inserter Screw Driver
• M9935041480: 15mm Shaver
• M9935041470: 14mm Shaver
• M9935041460: 13mm Shaver
• M9935041450: 12mm Shaver
• M9935041440: 11mm Shaver
• M9935041430: 10mm Shaver
• M9935041420: 9mm Shaver
• M9935041410: 8mm Shaver
• M9935041400: 7mm Shaver
• M9935041370: Non-Ratcheting T-Handle w/1/4" SQ QC
• M9935041350: Set Screw Starter Assembly (New)
• M9935041340: Spacer Grasper
• M9935041320: Spacer Remover
• M9935041300: Spacer Positioning
• M9935041290: Head Aligner
• M9935041280: Head Aligner
• M9935041260: 10-12mm Dilator
• M9935041250: 8-10mm Dilator