FIREBIRD

GUDID 18257200017393

8.5mm x 35mm Mono-Axial Reduction Screw, Self-Tapping

ORTHOFIX INC.

Bone-screw internal spinal fixation system

• Primary Device ID: 18257200017393
• NIH Device Record Key: 32a8c2c9-c1c8-48a8-ae1b-9953795c06ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIREBIRD
• Version Model Number: 61-7835
• Company DUNS: 927083808
• Company Name: ORTHOFIX 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(214)937-3199
• Email: osi-customerservice@orthofix.c
• Phone: +1(214)937-3199
• Email: osi-customerservice@orthofix.c
• 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
• 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 Dimensions

• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	18257200017393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081684

FDA Product Code

• NKB: Orthosis, spinal pedicle fixation, for degenerative disc disease

Sterilization

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

[18257200017393]

Moist Heat or Steam Sterilization

[18257200017393]

Moist Heat or Steam Sterilization

[18257200017393]

Moist Heat or Steam Sterilization

[18257200017393]

Moist Heat or Steam Sterilization

[18257200017393]

Moist Heat or Steam Sterilization

[18257200017393]

Moist Heat or Steam Sterilization

[18257200017393]

Moist Heat or Steam Sterilization

[18257200017393]

Moist Heat or Steam Sterilization

[18257200017393]

Moist Heat or Steam Sterilization

[18257200017393]

Moist Heat or Steam Sterilization

[18257200017393]

Moist Heat or Steam Sterilization

[18257200017393]

Moist Heat or Steam Sterilization

[18257200017393]

Moist Heat or Steam Sterilization

[18257200017393]

Moist Heat or Steam Sterilization

[18257200017393]

Moist Heat or Steam Sterilization

[18257200017393]

Moist Heat or Steam Sterilization

[18257200017393]

Moist Heat or Steam Sterilization

[18257200017393]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-24

On-Brand Devices [FIREBIRD]

• 18257200116515: 120mm Rod, Pre-Lordosed, anodized
• 18257200116508: 110mm Rod Pre-Lordosed, anodized
• 18257200116492: 100mm Rod, Pre-Lordosed, anodized
• 18257200116485: 90mm Rod, Pre-Lordosed, anodized
• 18257200116478: 80mm Rod, Pre-Lordosed, anodized
• 18257200116461: 75mm Rod, Pre-Lordosed, anodized
• 18257200116454: 70mm Rod, Pre-Lordosed, anodized
• 18257200116447: 65mm Rod, Pre-Lordosed, anodized
• 18257200116430: 60mm Rod, Pre-Lordosed, anodized
• 18257200116423: 55mm Rod, Pre-Lordosed, anodized
• 18257200116416: 50mm Rod, Pre-Lordosed, anodized
• 18257200116393: 40mm Rod, Pre-Lordosed, anodized
• 18257200116386: 35mm Rod, Pre-Lordosed, anodized
• 18257200116379: 800mm Rod, diameter 5.5mm, titanium, anodized
• 18257200116362: 600mm Rod, diameter 5.5mm, titanium, anodized
• 18257200116355: 450mm Rod, diameter 5.5 mm, titanium, anodized
• 18257200116348: 200mm Rod, diameter 5.5mm, titanium, anodized
• 18257200116331: 180mm Rod, diameter 5.5mm, titanium, anodized
• 18257200116324: 160mm Rod, diameter 5.5mm, titanium, anodized
• 18257200116317: 140mm Rod, diameter 5.5mm, titanium, anodized
• 18257200116300: 120mm Rod, diameter 5.5mm, titanium, anodized
• 18257200116294: 110mm Rod, diameter 5.5mm, titanium, anodized
• 18257200116287: 100mm Rod, diameter 5.5mm, titanium, anodized
• 18257200116270: 90mm Rod, diameter 5.5mm, titanium, anodized
• 18257200116263: 80mm Rod, diameter 5.5mm, titanium, anodized
• 18257200116256: 70mm Rod, diameter 5.5 mm, titanium, anodized
• 18257200116249: 60mm Rod, diameter 5.5 millimeter titanium anodized
• 18257200116232: 50mm Rod diameter 5.5mm titanium anodized
• 18257200116225: 40mm Rod, diameter 5.5mm titanium anodized
• 18257200114832: 7.5MMX95MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED
• 18257200114825: 7.5MMX90MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED
• 18257200114818: 7.5MMX85MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED
• 18257200114801: 7.5MMX80MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED
• 18257200114795: 7.5MMX75MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED
• 18257200114788: 7.5MMX70MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED
• 18257200114771: 7.5MMX65MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED
• 18257200114764: 7.5MMX60MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED
• 18257200114757: 7.5MMX55MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED
• 18257200114740: 7.5MMX50MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED
• 18257200114733: 7.5MMX45MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED
• 18257200114726: 7.5MMX40MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED
• 18257200114719: 7.5MMX35MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED
• 18257200114702: 7.5MMX30MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED
• 18257200114696: 7.5MMX25MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED
• 18257200114689: 7.5MM X 110MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED
• 18257200114672: 7.5MM X 100MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED
• 18257200114665: 6.5MMX95MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED
• 18257200114658: 6.5MMX90MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED
• 18257200114641: 6.5MMX85MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED
• 18257200114634: 6.5MMX80MM MODULAR BONE SCREW SELF-TAPPING, CANNULATED