FIREBIRD SFS

GUDID 18257200126767

4.0MMX40MM MULTI-AXIAL SELF-TAPPING SCREW, NON-MODULAR

ORTHOFIX INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 18257200126767
• NIH Device Record Key: 41801974-1274-4a0b-92e2-248466758e38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIREBIRD SFS
• Version Model Number: 44-3340
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	18257200126767 [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

[18257200126767]

Moist Heat or Steam Sterilization

[18257200126767]

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]

• 18257200130153: FIREBIRD 2.0 - 8.5MM ASSEMBLED CADDY
• 18257200130146: FIREBIRD 2.0 - 8.5MM MODULAR CADDY
• 18257200130139: FIREBIRD 2.0 - 7.5MM ASSEMBLED CADDY
• 18257200130122: FIREBIRD 2.0 - 7.5MM MODULAR CADDY
• 18257200130115: FIREBIRD 2.0 - 6.5MM ASSEMBLED CADDY - DOUBLE WIDE
• 18257200130108: FIREBIRD 2.0 - 6.5MM ASSEMBLED CADDY
• 18257200130092: FIREBIRD 2.0 - 6.5MM MODULAR CADDY - DOUBLE WIDE
• 18257200130085: FIREBIRD 2.0 - 6.5MM MODULAR CADDY
• 18257200130078: FIREBIRD 2.0 - 5.5MM ASSEMBLED CADDY - DOUBLE WIDE
• 18257200130061: FIREBIRD 2.0 - 5.5MM ASSEMBLED CADDY
• 18257200130054: FIREBIRD 2.0 - 5.5MM MODULAR CADDY - DOUBLE WIDE
• 18257200130047: FIREBIRD 2.0 - 5.5MM MODULAR CADDY
• 18257200130030: FIREBIRD 2.0 - 4.5MM ASSEMBLED CADDY
• 18257200130023: FIREBIRD 2.0 - 4.5MM MODULAR CADDY
• 18257200130016: FIREBIRD 2.0 - 4.0MM ASSEMBLED CADDY
• 18257200130009: FIREBIRD 2.0 - 4.0MM MODULAR CADDY
• 18257200128587: 7.5MM X 95MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128570: 7.5MM X 90MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128563: 7.5MM X 85MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128556: 7.5MM X 80MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128549: 7.5MM X 75MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128532: 7.5MM X 70MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128525: 7.5MM X 65MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128518: 7.5MM X 60MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128501: 7.5MM X 55MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128495: 7.5MM X 50MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128488: 7.5MM X 45MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128471: 7.5MM X 40MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128464: 7.5MM X 35MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128457: 7.5MM X 30MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128440: 7.5MM X 25MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128433: 7.5MM X 110MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128426: 7.5MM X 100MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128419: 6.5MM X 95MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128402: 6.5MM X 90MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128396: 6.5MM X 85MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128389: 6.5MM X 80MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128372: 6.5MM X 75MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128365: 6.5MM X 70MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128358: 6.5MM X 65MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128341: 6.5MM X 60MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128334: 6.5MM X 55MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128327: 6.5MM X 50MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128310: 6.5MM X 45MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128303: 6.5MM X 40MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128297: 6.5MM X 35MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128280: 6.5MM X 30MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128273: 6.5MM X 25MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128266: 6.5MM X 110MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
• 18257200128259: 6.5MM X 100MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED