Lumbar Interbody Fusion System (OLLIF) Oblique 27 mm Implants in Caddy O-2700

GUDID 00850014575328

Lumbar Interbody Fusion System (OLLIF) Oblique 27 mm Implants in Caddy

ADVANCED RESEARCH MEDICAL LLC

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• Primary Device ID: 00850014575328
• NIH Device Record Key: 75bbc78c-0da1-4566-9cab-2259600e553f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumbar Interbody Fusion System (OLLIF) Oblique 27 mm Implants in Caddy
• Version Model Number: O-2700
• Catalog Number: O-2700
• Company DUNS: 117201206
• Company Name: ADVANCED RESEARCH MEDICAL 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: true
• 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: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com
• Phone: (612)440-1865
• Email: info@advresmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850014575328 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173947

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

[00850014575328]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-24
• Device Publish Date: 2019-12-16

Devices Manufactured by ADVANCED RESEARCH MEDICAL LLC

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• 00840239800503 - N/A: 2024-05-03 XL-Shaper - Body
• 00840239800701 - N/A: 2024-05-01 XL-Graft Delivery Tube
• 00840239800657 - N/A: 2024-04-29 XL-Graft Tamp
• 00840239800671 - N/A: 2024-04-29 XL-Flexible Curette - Outer
• 00840239800527 - N/A: 2024-04-26 XL-Articulating Curette
• 00840239800572 - N/A: 2024-04-26 Instrument Platform - Decorticator
• 00840239800510 - N/A: 2024-04-24 XL-Shaper - Blades