FIREBIRD SFS;SFS

GUDID 18257200016440

15MM FIXED CROSS CONNECTOR

ORTHOFIX INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 18257200016440
• NIH Device Record Key: 73075658-76ff-4adf-bf38-bc1f5cfa85b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIREBIRD SFS;SFS
• Version Model Number: 57-5315
• Company DUNS: 927083808
• Company Name: ORTHOFIX INC.
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	18257200016440 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180179

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[18257200016440]

Moist Heat or Steam Sterilization

[18257200016440]

Moist Heat or Steam Sterilization

[18257200016440]

Moist Heat or Steam Sterilization

[18257200016440]

Moist Heat or Steam Sterilization

[18257200016440]

Moist Heat or Steam Sterilization

[18257200016440]

Moist Heat or Steam Sterilization

[18257200016440]

Moist Heat or Steam Sterilization

[18257200016440]

Moist Heat or Steam Sterilization

[18257200016440]

Moist Heat or Steam Sterilization

[18257200016440]

Moist Heat or Steam Sterilization

[18257200016440]

Moist Heat or Steam Sterilization

[18257200016440]

Moist Heat or Steam Sterilization

[18257200016440]

Moist Heat or Steam Sterilization

[18257200016440]

Moist Heat or Steam Sterilization

[18257200016440]

Moist Heat or Steam Sterilization

[18257200016440]

Moist Heat or Steam Sterilization

[18257200016440]

Moist Heat or Steam Sterilization

[18257200016440]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-20
• Device Publish Date: 2019-03-12

On-Brand Devices [FIREBIRD SFS;SFS]

• 18257200056125: ROD ROCKER SFS HOOK SYSTEM
• 18257200016464: 19MM FIXED CROSS CONNECTOR
• 18257200016457: 17MM FIXED CROSS CONNECTOR
• 18257200016440: 15MM FIXED CROSS CONNECTOR