Arena-C

GUDID 00190361023142

Arena-C HA, 12x15, Straight 12mm

SPINEFRONTIER, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00190361023142
• NIH Device Record Key: c84b046e-8f4f-4e43-a084-866071410345
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arena-C
• Version Model Number: 01-72007-12
• 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

• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190361023142 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142026

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

[00190361023142]

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: 2017-12-01

On-Brand Devices [Arena-C]

• 00190361023173: Arena-C HA, 11X17 Straight, 12mm
• 00190361023166: Arena-C HA, 11X17 Straight, 11mm
• 00190361023159: Arena-C HA, 11X17 Straight, 10mm
• 00190361023142: Arena-C HA, 12x15, Straight 12mm
• 00190361023135: Arena-C HA, 12x15, Straight 11mm
• 00190361023128: Arena-C HA, 12x15, Straight 10mm
• 00190361023111: Arena-C HA, 11X17 Straight, 9mm
• 00190361023104: Arena-C HA, 11X17 Straight, 8mm
• 00190361023098: Arena-C HA Straight 7mm 11x17 IBFD
• 00190361023081: Arena-C HA Straight 6mm 11x17 IBFD
• 00190361023074: Arena-C HA Straight 5mm 11x17 IBFD
• 00190361023067: 12x15 Arena-C PEEK HA Straight 5mm
• 00190361023050: 12x15 Arena-C PEEK HA Straight 6mm
• 00190361023043: 12x15 Arena-C PEEK HA Straight 7mm
• 00190361023036: 12x15 Arena-C PEEK HA Straight 8mm
• 00190361023029: 12x15 Arena-C PEEK HA Straight 9mm