GALILEO SCREWS SET

GUDID 00848665039009

ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

Surgical instrument/implant rack

• Primary Device ID: 00848665039009
• NIH Device Record Key: 96616aae-3b61-4ded-b26a-22b2862ac728
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GALILEO SCREWS SET
• Version Model Number: 9964-000
• Company DUNS: 117858154
• Company Name: ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com
• Phone: (310) 533-9966
• Email: ATI_Regulatory@arthrex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848665039009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021008

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

[00848665039009]

Moist Heat or Steam Sterilization

[00848665039009]

Moist Heat or Steam Sterilization

[00848665039009]

Moist Heat or Steam Sterilization

[00848665039009]

Moist Heat or Steam Sterilization

[00848665039009]

Moist Heat or Steam Sterilization

[00848665039009]

Moist Heat or Steam Sterilization

[00848665039009]

Moist Heat or Steam Sterilization

[00848665039009]

Moist Heat or Steam Sterilization

[00848665039009]

Moist Heat or Steam Sterilization

[00848665039009]

Moist Heat or Steam Sterilization

[00848665039009]

Moist Heat or Steam Sterilization

[00848665039009]

Moist Heat or Steam Sterilization

[00848665039009]

Moist Heat or Steam Sterilization

[00848665039009]

Moist Heat or Steam Sterilization

[00848665039009]

Moist Heat or Steam Sterilization

[00848665039009]

Moist Heat or Steam Sterilization

[00848665039009]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-18
• Device Publish Date: 2022-02-10

Devices Manufactured by ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

• 00848665028980 - SEMI-TUBULAR PLATE, 13-HOLE: 2024-11-13
• 00848665029000 - SEMI-TUBULAR PLATE, 15-HOLE: 2024-11-13
• 00848665029017 - SEMI-TUBULAR PLATE, 17-HOLE: 2024-11-13
• 00848665029024 - SEMI-TUBULAR PLATE, 19-HOLE: 2024-11-13
• 00848665029031 - SEMI-TUBULAR PLATE, 21-HOLE: 2024-11-13
• 00848665029048 - STRAIGHT PLATE, 13-HOLE: 2024-11-13
• 00848665029055 - STRAIGHT PLATE, 15-HOLE: 2024-11-13
• 00848665029062 - STRAIGHT PLATE, 17-HOLE: 2024-11-13