Aries-TS TSLIF Lumbar Interbody System 1100-1521S

GUDID B06211001521

10x32x08, 7 Deg, Sterile, TSLIF Interbody, Aries-TS

Osseus Fusion Systems, LLC

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• Primary Device ID: B06211001521
• NIH Device Record Key: bed61344-f81e-4e47-b95e-2bbdbdee2872
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aries-TS TSLIF Lumbar Interbody System
• Version Model Number: 1100-1521S
• Catalog Number: 1100-1521S
• 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	B06211001521 [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: 2022-11-14
• Device Publish Date: 2022-11-04

On-Brand Devices [Aries-TS TSLIF Lumbar Interbody System]

• B06211000325: 10x28x12, 0 degree, TSLIF
• B06211000324: 10x28x11, 0 degree, TSLIF
• B06211000323: 10x28x10, 0 degree, TSLIF
• B06211000322: 10x28x09, 0 degree, TSLIF
• B06211000321: 10x28x8, 0 degree, TSLIF
• B06211000320: 10x28x7, 0 degree, TSLIF
• B06211000125: 10x24x12, 0 degree, TSLIF
• B06211000124: 10x24x11, 0 degree, TSLIF
• B06211000123: 10x24x10, 0 degree, TSLIF
• B06211000122: Aries-TS TSLIF Lumbar Interbody System
• B06211000121: 10x24x8, 0 degree, TSLIF
• B06211000120: 10x24x7, 0 degree, TSLIF
• B06211001529: 10x32x16, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001528: 10x32x15, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001527: 10x32x14, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001526: 10x32x13, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001525: 10x32x12, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001524: 10x32x11, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001523: 10x32x10, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001522: 10x32x09, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001521: 10x32x08, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001520: 10x32x07, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001329: 10x28x16, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001328: 10x28x15, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001327: 10x28x14, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001326: 10x28x13, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001325: 10x28x12, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001324: 10x28x11, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001323: 10x28x10, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001322: 10x28x09, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001321: 10x28x08, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001320: 10x28x07, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001129: 10x24x16, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001128: 10x24x15, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001127: 10x24x14, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001126: 10x24x13, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001125: 10x24x12, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001124: 10x32x11, 0 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001123: 10x24x10, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001122: 10x24x14, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001121: 10x24x08, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211001120: 10x24x07, 7 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211000523: 10x32x10, 0 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211000522: 10x32x09, 0 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211000521: 10x32x08, 0 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211000520: Aries-TS TSLIF Lumbar Interbody System
• B06211000329: 10x28x16, 0 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211000328: 10x28x15, 0 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211000327: 10x28x14, 0 Deg, Sterile, TSLIF Interbody, Aries-TS
• B06211000326: 10x28x13, 0 Deg, Sterile, TSLIF Interbody, Aries-TS