Firebird SI Fusion

GUDID 18257200140107

11MM X 35MM FIREBIRD SI SCREW, FIREBIRD SI FUSION SYSTEM, STERILE

Orthofix US LLC

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 18257200140107
• NIH Device Record Key: f6d38456-5e56-4bf7-b2f5-c51144af6049
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Firebird SI Fusion
• Version Model Number: 18-1035SP
• Company DUNS: 927083808
• Company Name: Orthofix US 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	18257200140107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183342

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-20
• Device Publish Date: 2024-12-12

On-Brand Devices [Firebird SI Fusion]

• 18257200140114: 11MM X 40MM FIREBIRD SI SCREW, FIREBIRD SI FUSION SYSTEM, STERILE
• 18257200140107: 11MM X 35MM FIREBIRD SI SCREW, FIREBIRD SI FUSION SYSTEM, STERILE