Firebird SI Navigation System

GUDID 18257200164936

9mm DRILL, NAVIGATED

Orthofix US LLC

Fluted surgical drill bit, reusable

• Primary Device ID: 18257200164936
• NIH Device Record Key: 7f10e8cc-e0c5-4217-be50-5c06f15b9b4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Firebird SI Navigation System
• Version Model Number: 18-1909
• 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: 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(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)937-3199
• Email: osi-customerservice@orthofix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	18257200164936 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252088

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[18257200164936]

Moist Heat or Steam Sterilization

[18257200164936]

Moist Heat or Steam Sterilization

[18257200164936]

Moist Heat or Steam Sterilization

[18257200164936]

Moist Heat or Steam Sterilization

[18257200164936]

Moist Heat or Steam Sterilization

[18257200164936]

Moist Heat or Steam Sterilization

[18257200164936]

Moist Heat or Steam Sterilization

[18257200164936]

Moist Heat or Steam Sterilization

[18257200164936]

Moist Heat or Steam Sterilization

[18257200164936]

Moist Heat or Steam Sterilization

[18257200164936]

Moist Heat or Steam Sterilization

[18257200164936]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-03
• Device Publish Date: 2025-11-25

On-Brand Devices [Firebird SI Navigation System]

• 18257200165148: FIREBIRD SI NAV TRAJECTORY GUIDE
• 18257200165131: PIN SLEEVE
• 18257200165124: DRILL GUIDE
• 18257200165223: FIREBIRD SI NAVIGATED INTRUMENT CASE
• 18257200165193: MDT INLINE ADAPTER
• 18257200164950: 12mm DRILL, NAVIGATED
• 18257200164943: 11mm DRILL, NAVIGATED
• 18257200164936: 9mm DRILL, NAVIGATED
• 18257200164929: SCREW DRIVER, NAVIGATED