CAPTURING ROD, GALILEO™ LAG SCREW

GUDID 00848665021455

ADVANCED ORTHOPEDIC SOLUTIONS INC

Orthopaedic instrument surgical connector

• Primary Device ID: 00848665021455
• NIH Device Record Key: 98364ed9-cc5a-4270-b6a1-5cd832d50073
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAPTURING ROD, GALILEO™ LAG SCREW
• Version Model Number: 0455-100
• Company DUNS: 117858154
• Company Name: ADVANCED ORTHOPEDIC SOLUTIONS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Expiration Date: true
• 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
• 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	00848665021455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021008

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories
• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00848665021455]

Moist Heat or Steam Sterilization

[00848665021455]

Moist Heat or Steam Sterilization

[00848665021455]

Moist Heat or Steam Sterilization

[00848665021455]

Moist Heat or Steam Sterilization

[00848665021455]

Moist Heat or Steam Sterilization

[00848665021455]

Moist Heat or Steam Sterilization

[00848665021455]

Moist Heat or Steam Sterilization

[00848665021455]

Moist Heat or Steam Sterilization

[00848665021455]

Moist Heat or Steam Sterilization

[00848665021455]

Moist Heat or Steam Sterilization

[00848665021455]

Moist Heat or Steam Sterilization

[00848665021455]

Moist Heat or Steam Sterilization

[00848665021455]

Moist Heat or Steam Sterilization

[00848665021455]

Moist Heat or Steam Sterilization

[00848665021455]

Moist Heat or Steam Sterilization

[00848665021455]

Moist Heat or Steam Sterilization

[00848665021455]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-12-07
• Device Publish Date: 2016-02-23

Devices Manufactured by ADVANCED ORTHOPEDIC SOLUTIONS INC

• 00848665027679 - COUNTERSINK: 2020-06-23
• 00848665000658 - AOS Drill, AO Style, 2.9mm x 100mm: 2020-06-08
• 00848665001235 - AOS CANCELLOUS TAP 3.5mm: 2020-06-08
• 00848665027624 - SUPRAPATELLAR TIBIAL ENTRY SHEATH: 2020-06-08
• 00848665028041 - T10 Screwdriver, Short: 2020-06-08
• 00848665028096 - 3.5mm Calibrated Drill: 2020-06-08
• 00848665028119 - AOS 2.6mm Solid Reamer: 2020-06-08
• 00848665028782 - T10 Screwdriver, Solid: 2020-06-08