ICON

GUDID 18257200065431

Reduction Screw Body with Extended Tab

ORTHOFIX INC.

Bone-screw internal spinal fixation system

• Primary Device ID: 18257200065431
• NIH Device Record Key: 92a5be2a-f93d-4b37-891c-247c0a7ee693
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICON
• Version Model Number: 68-9000
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	18257200065431 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111448

FDA Product Code

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

Sterilization

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

[18257200065431]

Moist Heat or Steam Sterilization

[18257200065431]

Moist Heat or Steam Sterilization

[18257200065431]

Moist Heat or Steam Sterilization

[18257200065431]

Moist Heat or Steam Sterilization

[18257200065431]

Moist Heat or Steam Sterilization

[18257200065431]

Moist Heat or Steam Sterilization

[18257200065431]

Moist Heat or Steam Sterilization

[18257200065431]

Moist Heat or Steam Sterilization

[18257200065431]

Moist Heat or Steam Sterilization

[18257200065431]

Moist Heat or Steam Sterilization

[18257200065431]

Moist Heat or Steam Sterilization

[18257200065431]

Moist Heat or Steam Sterilization

[18257200065431]

Moist Heat or Steam Sterilization

[18257200065431]

Moist Heat or Steam Sterilization

[18257200065431]

Moist Heat or Steam Sterilization

[18257200065431]

Moist Heat or Steam Sterilization

[18257200065431]

Moist Heat or Steam Sterilization

[18257200065431]

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 [ICON]

• 18257200065431: Reduction Screw Body with Extended Tab
• 18257200065417: Multi-axial Reduction Body
• 18257200052837: 14mm Offset Body Assembly
• 18257200052820: 11mm Offset Body Assembly
• 18257200052813: 8mm Offset Body Assembly
• 18257200052806: Multi Axial Body
• 18257200052790: 8.5mm x 80mm Mono Axial Screw
• 18257200052783: 8.5mm x 75mm Mono Axial Screw
• 18257200052776: 8.5mm x 70mm Mono Axial Screw
• 18257200052769: 8.5mm x 65mm Mono Axial Screw
• 18257200052752: 8.5mm x 60mm Mono Axial Screw
• 18257200052745: 8.5mm x 55mm Mono Axial Screw
• 18257200052738: 8.5mm x 50mm Mono Axial Screw
• 18257200052721: 8.5mm x 45mm Mono Axial Screw
• 18257200052714: 8.5mm x 40mm Mono Axial Screw
• 18257200052707: 8.5mm x 35mm Mono Axial Screw
• 18257200052691: 8.5mm x 30mm Mono Axial Screw
• 18257200052684: 8.5mm x 25mm Mono Axial Screw
• 18257200052677: 7.5mm x 80mm Mono Axial Screw
• 18257200052660: 7.5mm x 75mm Mono Axial Screw
• 18257200052653: 7.5mm x 70mm Mono Axial Screw
• 18257200052646: 7.5mm x 65mm Mono Axial Screw
• 18257200052639: 7.5mm x 60mm Mono Axial Screw
• 18257200052622: 7.5mm x 55mm Mono Axial Screw
• 18257200052615: 7.5mm x 50mm Mono Axial Screw
• 18257200052608: 7.5mm x 45mm Mono Axial Screw
• 18257200052592: 7.5mm x 40mm Mono Axial Screw
• 18257200052585: 7.5mm x 35mm Mono Axial Screw
• 18257200052578: 7.5mm x 30mm Mono Axial Screw
• 18257200052561: 7.5mm x 25mm Mono Axial Screw
• 18257200052554: 6.5mm x 80mm Mono Axial Screw
• 18257200052547: 6.5mm x 75mm Mono Axial Screw
• 18257200052530: 6.5mm x 70mm Mono Axial Screw
• 18257200052523: 6.5mm x 65mm Mono Axial Screw
• 18257200052516: 6.5mm x 60mm Mono Axial Screw
• 18257200052509: 6.5mm x 55mm Mono Axial Screw
• 18257200052493: 6.5mm x 50mm Mono Axial Screw
• 18257200052486: 6.5mm x 45mm Mono Axial Screw
• 18257200052479: 6.5mm x 40mm Mono Axial Screw
• 18257200052462: 6.5mm x 35mm Mono Axial Screw
• 18257200052455: 6.5mm x 30mm Mono Axial Screw
• 18257200052448: 6.5mm x 25mm Mono Axial Screw
• 18257200052431: 5.5mm x 75mm Mono Axial Screw
• 18257200052424: 5.5mm x 70mm Mono Axial Screw
• 18257200052417: 5.5mm x 65mm Mono Axial Screw
• 18257200052400: 5.5mm x 60mm Mono Axial Screw
• 18257200052394: 5.5mm x 55mm Mono Axial Screw
• 18257200052387: 5.5mm x 50mm Mono Axial Screw
• 18257200052370: 5.5mm x 45mm Mono Axial Screw
• 18257200052363: 5.5mm x 40mm Mono Axial Screw