Aries-TC 1200-0707

GUDID B06212000707

10x36x14, 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: B06212000707
• NIH Device Record Key: 3c4e79e4-6229-47dd-b915-8dc04b324a33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aries-TC
• Version Model Number: 1200-0707
• Catalog Number: 1200-0707
• 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	B06212000707 [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