Aries- TC 1200-0200

GUDID B06212000200

10x30x07, 0 Deg, Sterile, TLIF Interbody, Aries-TC

Osseus Fusion Systems, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: B06212000200
• NIH Device Record Key: b3ddecba-5d17-4a03-ad85-08c5f8c997a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aries- TC
• Version Model Number: 1200-0200
• Catalog Number: 1200-0200
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B06212000200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181347

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-30
• Device Publish Date: 2021-12-22

Devices Manufactured by Osseus Fusion Systems, LLC

• B06224200000 - Black Diamond POCT: 2023-06-22 Locking Cap, Black Diamond POCT
• B06224200001 - Black Diamond POCT: 2023-06-22 Locking Cap, HH Connector, Black Diamond POCT
• B06224200002 - Black Diamond POCT: 2023-06-22 Locking Cap Nut, HH Connector, Black Diamond POCT
• B06224200025 - Black Diamond POCT: 2023-06-22 3.5x25mm Rod, Curved, Black Diamond POCT
• B06224200030 - Black Diamond POCT: 2023-06-22 3.5x30mm Rod, Curved, Black Diamond POCT
• B06224200035 - Black Diamond POCT: 2023-06-22 3.5x35mm Rod, Curved, Black Diamond POCT
• B06224200040 - Black Diamond POCT: 2023-06-22 3.5x40mm Rod, Curved, Black Diamond POCT
• B06224200045 - Black Diamond POCT: 2023-06-22 3.5x45mm Rod, Curved, Black Diamond POCT