ICON SFS, SFS

GUDID 18257200051601

60mm Prelordesed Rod

ORTHOFIX INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 18257200051601
• NIH Device Record Key: 1d8f4a5c-04b8-40cc-80e7-58129e4254bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICON SFS, SFS
• Version Model Number: 54-2060
• 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: false
• RX Perscription: false
• 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

• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	18257200051601 [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

[18257200051601]

Moist Heat or Steam Sterilization

[18257200051601]

Moist Heat or Steam Sterilization

[18257200051601]

Moist Heat or Steam Sterilization

[18257200051601]

Moist Heat or Steam Sterilization

[18257200051601]

Moist Heat or Steam Sterilization

[18257200051601]

Moist Heat or Steam Sterilization

[18257200051601]

Moist Heat or Steam Sterilization

[18257200051601]

Moist Heat or Steam Sterilization

[18257200051601]

Moist Heat or Steam Sterilization

[18257200051601]

Moist Heat or Steam Sterilization

[18257200051601]

Moist Heat or Steam Sterilization

[18257200051601]

Moist Heat or Steam Sterilization

[18257200051601]

Moist Heat or Steam Sterilization

[18257200051601]

Moist Heat or Steam Sterilization

[18257200051601]

Moist Heat or Steam Sterilization

[18257200051601]

Moist Heat or Steam Sterilization

[18257200051601]

Moist Heat or Steam Sterilization

[18257200051601]

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: 2016-03-14

On-Brand Devices [ICON SFS, SFS]

• 18257200051649: 100mm Prelordesed Rod
• 18257200051632: 90mm Prelordesed Rod
• 18257200051625: 80mm Prelordesed Rod
• 18257200051618: 70mm Prelordesed Rod
• 18257200051601: 60mm Prelordesed Rod
• 18257200051595: 50mm Prelordesed Rod
• 18257200051588: 40mm Prelordesed Rod