GALILEO® TROCHANTERIC NAIL, RIGHT, Ø11mm x 45cm x 125°

GUDID 00848665014563

ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile Femur nail, non-sterile

• Primary Device ID: 00848665014563
• NIH Device Record Key: f824c6f0-492d-4833-b02f-2440c9a7d781
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GALILEO® TROCHANTERIC NAIL, RIGHT, Ø11mm x 45cm x 125°
• Version Model Number: 1023-450
• 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: true
• 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: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com
• Phone: (310) 533-9966
• Email: regaffairs@aosortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848665014563 [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

[00848665014563]

Moist Heat or Steam Sterilization

[00848665014563]

Moist Heat or Steam Sterilization

[00848665014563]

Moist Heat or Steam Sterilization

[00848665014563]

Moist Heat or Steam Sterilization

[00848665014563]

Moist Heat or Steam Sterilization

[00848665014563]

Moist Heat or Steam Sterilization

[00848665014563]

Moist Heat or Steam Sterilization

[00848665014563]

Moist Heat or Steam Sterilization

[00848665014563]

Moist Heat or Steam Sterilization

[00848665014563]

Moist Heat or Steam Sterilization

[00848665014563]

Moist Heat or Steam Sterilization

[00848665014563]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-15
• Device Publish Date: 2021-03-05

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• 00848665032734 - MINIMALLY INVASIVE CALCANEAL PLATE, RIGHT,SMALL: 2024-02-19
• 00848665032741 - MINIMALLY INVASIVE CALCANEAL PLATE, RIGHT, MEDIUM: 2024-02-19
• 00848665032758 - MINIMALLY INVASIVE CALCANEAL PLATE, RIGHT, LARGE: 2024-02-19
• 00848665034066 - BENDING TEMPLATE,MINIMALLY INVASIVE CALCANEAL PLATE, EXTRA SMALL: 2024-02-19
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