Arena-C®

GUDID 00190361021063

Arena-C, Lordotic, 12x15x12mm

SPINEFRONTIER, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00190361021063
• NIH Device Record Key: 51c43289-3a73-46b9-bd34-b47c6e1f5014
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arena-C®
• Version Model Number: 01-72001-12
• Company DUNS: 002003243
• Company Name: SPINEFRONTIER, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com

Device Dimensions

• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190361021063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113518

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

[00190361021063]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-04-15

On-Brand Devices [Arena-C®]

• 00190361037040: Trial Rasp, No Stop, Assembly, Straight, 12mm
• 00190361037033: Trial Rasp, No Stop, Assembly, Straight, 11mm
• 00190361037026: Trial Rasp, No Stop, Assembly, Straight, 10mm
• 00190361037019: Trial Rasp, No Stop, Assembly, Straight, 9mm
• 00190361037002: Trial Rasp, No Stop, Assembly, Straight, 8mm
• 00190361036999: Trial Rasp, No Stop, Assembly, Straight, 7mm
• 00190361036982: Trial Rasp, No Stop, Assembly, Straight, 6mm
• 00190361036975: Trial Rasp, No Stop, Assembly, Straight, 5mm
• 00190361036968: Trial Rasp, Assembly, Straight, 12mm
• 00190361036951: Trial Rasp, Assembly, Straight, 11mm
• 00190361036944: Trial Rasp, Assembly, Straight, 10mm
• 00190361036937: Trial Rasp, Assembly, Straight, 9mm
• 00190361036920: Trial Rasp, Assembly, Straight, 8mm
• 00190361036913: Trial Rasp, Assembly, Straight, 7mm
• 00190361036906: Trial Rasp, Assembly, Straight, 6mm
• 00190361036890: Trial Rasp, Assembly, Straight, 5mm
• 00190361036883: Trial Rasp, No Stop, Assembly, Lordotic, 12mm
• 00190361036876: Trial Rasp, No Stop, Assembly, Lordotic, 11mm
• 00190361036869: Trial Rasp, No Stop, Assembly, Lordotic, 10mm
• 00190361036852: Trial Rasp, No Stop, Assembly, Lordotic, 9mm
• 00190361036845: Trial Rasp, No Stop, Assembly, Lordotic, 8mm
• 00190361036838: Trial Rasp, No Stop, Assembly, Lordotic, 7mm
• 00190361036821: Trial Rasp, No Stop, Assembly, Lordotic, 6mm
• 00190361036814: Trial Rasp, No Stop, Assembly, Lordotic, 5mm
• 00190361036807: Trial Rasp, Assembly, Lordotic, 12mm
• 00190361036791: Trial Rasp, Assembly, Lordotic, 11mm
• 00190361036784: Trial Rasp, Assembly, Lordotic, 10mm
• 00190361036777: Trial Rasp, Assembly, Lordotic, 9mm
• 00190361036760: Trial Rasp, Assembly, Lordotic, 8mm
• 00190361036753: Trial Rasp, Assembly, Lordotic, 7mm
• 00190361036746: Trial Rasp, Assembly, Lordotic, 6mm
• 00190361036739: Trial Rasp, Assembly, Lordotic, 5mm
• 00190361036722: 13X15 Trial Spacer, No Stop, Straight, 12mm
• 00190361036715: 13X15 Trial Spacer, No Stop, Straight, 11mm
• 00190361036708: 13X15 Trial Spacer, No Stop, Straight, 10mm
• 00190361036692: 13X15 Trial Spacer, No Stop, Straight, 9mm
• 00190361036685: 13X15 Trial Spacer, No Stop, Straight, 8mm
• 00190361036678: 13X15 Trial Spacer, No Stop, Straight, 7mm
• 00190361036661: 13X15 Trial Spacer, No Stop, Straight, 6mm
• 00190361036654: 13X15 Trial Spacer, No Stop, Straight, 5mm
• 00190361036647: Trial Spacer, Assembly, Straight, 12mm
• 00190361036630: Trial Spacer, Assembly, Straight, 11mm
• 00190361036623: Trial Spacer, Assembly, Straight, 10mm
• 00190361036616: Trial Spacer, Assembly, Straight, 9mm
• 00190361036609: Trial Spacer, Assembly, Straight, 8mm
• 00190361036593: Trial Spacer, Assembly, Straight, 7mm
• 00190361036586: Trial Spacer, Assembly, Straight, 6mm
• 00190361036579: Trial Spacer, Assembly, Straight, 5mm
• 00190361036562: 13X15 Trial Spacer, No Stop, Lordotic, 12mm
• 00190361036555: 13X15 Trial Spacer, No Stop, Lordotic, 11mm