Dorado® Wide

GUDID 00190361006145

Wide, Straight,16 x 25MM, Dorado IBC

SPINEFRONTIER, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00190361006145
• NIH Device Record Key: 71844821-5fb7-4ce2-b93e-7a1012bcc06f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dorado® Wide
• Version Model Number: IM2026
• 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: 25 Millimeter
• Length: 25 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190361006145 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091638

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00190361006145]

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 [Dorado® Wide]

• 00190361006152: Dorado Wide Straight, Bullet, 15x25mm
• 00190361006145: Wide, Straight,16 x 25MM, Dorado IBC