Aries-T Lumbar Interbody System 1150-7110

GUDID B06211507110

10" Bone Funnel Impactor

Osseus Fusion Systems, LLC

Bone graft funnel

• Primary Device ID: B06211507110
• NIH Device Record Key: 6619f363-b98e-4ff5-8c22-7034a70f111f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aries-T Lumbar Interbody System
• Version Model Number: 1150-7110
• Catalog Number: 1150-7110
• Company DUNS: 933442068
• Company Name: Osseus Fusion Systems, 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B06211507110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181347

FDA Product Code

• MDM: Instrument, Manual, Surgical, General Use

Sterilization

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

[B06211507110]

Moist Heat or Steam Sterilization

[B06211507110]

Moist Heat or Steam Sterilization

[B06211507110]

Moist Heat or Steam Sterilization

[B06211507110]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-21
• Device Publish Date: 2020-05-13

On-Brand Devices [Aries-T Lumbar Interbody System]

• B06211507110: 10" Bone Funnel Impactor
• B06211503000: Aries TSLIF Inserter