Aries-TC 1200-0209

GUDID B06212000209

10x30x16, 0 Deg, Sterile, TLIF Interbody, Aries-TC

Osseus Fusion Systems, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: B06212000209
• NIH Device Record Key: a3e3d237-0c1d-48e0-8881-91762732d45d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aries-TC
• Version Model Number: 1200-0209
• Catalog Number: 1200-0209
• 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	B06212000209 [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

On-Brand Devices [Aries-TC]

• B06212506010: TCLIF Angled Tamp, Aries-TC
• B06212506000: TCLIF Straight Tamp, Aries-TC
• B06212503000: TCLIF Insterter, Aries-TC
• B06212501707: TCLIF Trial, 10x36x14, 7 Deg, Aries-TC
• B06212501706: TCLIF Trial, 10x36x13, 7 Deg, Aries-TC
• B06212501705: TCLIF Trial, 10x36x12, 7 Deg, Aries-TC
• B06212501704: TCLIF Trial, 10x36x11, 7 Deg, Aries-TC
• B06212501703: TCLIF Trial, 10x36x10, 7 Deg, Aries-TC
• B06212501702: TCLIF Trial, 10x36x09, 7 Deg, Aries-TC
• B06212501701: TCLIF Trial, 10x36x08, 7 Deg, Aries-TC
• B06212501700: TCLIF Trial, 10x36x07, 7 Deg, Aries-TC
• B06212501207: TCLIF Trial, 10x30x14, 7 Deg, Aries-TC
• B06212501206: TCLIF Trial, 10x30x13, 7 Deg, Aries-TC
• B06212501205: TCLIF Trial, 10x30x12, 7 Deg, Aries-TC
• B06212501204: TCLIF Trial, 10x30x11, 7 Deg, Aries-TC
• B06212501203: TCLIF Trial, 10x30x10, 7 Deg, Aries-TC
• B06212501202: TCLIF Trial, 10x30x09, 7 Deg, Aries-TC
• B06212501201: TCLIF Trial, 10x30x08, 7 Deg, Aries-TC
• B06212501200: TCLIF Trial, 10x30x07, 7 Deg, Aries-TC
• B06212001709: 10x36x16, 7 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212001708: 10x36x15, 7 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212001707: 10x36x14, 7 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212001706: 10x36x13, 7 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212001705: 10x36x12, 7 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212001704: 10x36x11, 7 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212001703: 10x36x10, 7 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212001702: 10x36x09, 7 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212001701: 10x36x08, 7 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212001700: 10x36x07, 7 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212001209: 10x30x16, 7 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212001208: 10x30x15, 7 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212001207: 10x30x14, 7 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212001206: 10x30x13, 7 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212001205: 10x30x12, 7 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212001204: 10x30x11, 7 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212001203: 10x30x10, 7 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212001202: 10x30x09, 7 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212001201: 10x30x08, 7 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212001200: 10x30x07, 7 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212000709: 10x36x16, 0 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212000708: 10x36x15, 0 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212000707: 10x36x14, 0 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212000706: 10x36x13, 0 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212000705: 10x36x12, 0 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212000704: 10x36x11, 0 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212000703: 10x36x10, 0 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212000702: 10x36x09, 0 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212000700: 10x36x07, 0 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212000209: 10x30x16, 0 Deg, Sterile, TLIF Interbody, Aries-TC
• B06212000208: 10x30x15, 0 Deg, Sterile, TLIF Interbody, Aries-TC