Aries-L Lateral Lumbar Interbody System 1450-5244

GUDID B06214505244

20x60x16, 12 degree trial, LLIF

Osseus Fusion Systems, LLC

Spinal implant trial

• Primary Device ID: B06214505244
• NIH Device Record Key: ea150351-800e-47af-adda-20f87428a5d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aries-L Lateral Lumbar Interbody System
• Version Model Number: 1450-5244
• Catalog Number: 1450-5244
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	B06214505244 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181347

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

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

[B06214505244]

Moist Heat or Steam Sterilization

[B06214505244]

Moist Heat or Steam Sterilization

[B06214505244]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-19
• Device Publish Date: 2020-05-11

On-Brand Devices [Aries-L Lateral Lumbar Interbody System]

• B06214001220: 20x50x8, 8 degree, LLIF
• B06214001214: 20x45x16, 8 degree, LLIF
• B06214001213: 20x45x14, 8 degree, LLIF
• B06214001212: 20x45x12, 8 degree, LLIF
• B06214001211: 20x45x10, 8 degree, LLIF
• B06214001210: 20x45x8, 8 degree, LLIF
• B06214001204: 20x40x16, 8 degree, LLIF
• B06214001203: 20x40x14, 8 degree, LLIF
• B06214001202: 20x40x12, 8 degree, LLIF
• B06214001201: 20x40x10, 8 degree, LLIF
• B06214001200: 20x40x8, 8 degree, LLIF
• B06214000244: 20x60x16, 0 degree, LLIF
• B06214000243: 20x60x14, 0 degree, LLIF
• B06214000242: 20x60x12, 0 degree, LLIF
• B06214000241: 20x60x8, 0 degree, LLIF
• B06214000240: 20x60x8, 0 degree, LLIF
• B06214000234: 20x55x16, 0 degree, LLIF
• B06214000233: 20x55x14, 0 degree, LLIF
• B06214000232: 20x55x12, 0 degree, LLIF
• B06214000231: 20x55x10, 0 degree, LLIF
• B06214000230: 20x55x8, 0 degree, LLIF
• B06214000224: 20x50x16, 0 degree, LLIF
• B06214000223: 20x50x14, 0 degree, LLIF
• B06214000222: 14000222
• B06214000221: 20x50x10, 0 degree, LLIF
• B06214000220: 20x50x8, 0 degree, LLIF
• B06214000214: 20x45x16, 0 Degree, LLIF
• B06214000213: 20x45x14, 0 degree, LLIF
• B06214000212: 20x45x12, 0 Degree LLIF
• B06214000211: 20x45x10, 0 degree LLIF
• B06214000210: 20x45x8, 0 degree LLIF
• B06214000204: 20x40x14, 0 degree LLIF
• B06214000203: 20x40x14, 0 degree, LLIF
• B06214000202: 1400-0202
• B06214000201: 1400-0201
• B06214000200: 1400-0200
• B06214005221: 20x50x10, 12 degree, LLIF
• B06214005220: 20x50x8,12 degree, LLIF
• B06214005214: 20x45x16, 12 degree, LLIF
• B06214005213: 20x45x14, 12 degree, LLIF
• B06214005211: 20x45x10, 12 degree, LLIF
• B06214005210: 20x45x8, 12 degree, LLIF
• B06214005204: 20x40x16, 12 degree, LLIF
• B06214005203: 20x40x14, 12 degree, LLIF
• B06214005202: 20x40x12, 12 degree, LLIF
• B06214005201: 20x40x10, 12 degree, LLIF
• B06214005200: 20x40x8, 12 degree, LLIF
• B06214001244: 20x60x16, 8 degree, LLIF
• B06214001243: 20x60x14, 8 degree, LLIF
• B06214001242: 20x60x12, 8 degree, LLIF