Aries- TC 1200-0200

GUDID B06212000200

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

Osseus Fusion Systems, LLC

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage 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