ASCENT;ASCENT LE;CENTURION

GUDID 18257200063413

CROSS CONNECTOR TORQUE LIMITING DRIVER

ORTHOFIX INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 18257200063413
• NIH Device Record Key: 29f46198-c823-4a3a-be87-b78a43d8b718
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASCENT;ASCENT LE;CENTURION
• Version Model Number: 65-1083
• 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
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• 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	18257200063413 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111183

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[18257200063413]

Moist Heat or Steam Sterilization

[18257200063413]

Moist Heat or Steam Sterilization

[18257200063413]

Moist Heat or Steam Sterilization

[18257200063413]

Moist Heat or Steam Sterilization

[18257200063413]

Moist Heat or Steam Sterilization

[18257200063413]

Moist Heat or Steam Sterilization

[18257200063413]

Moist Heat or Steam Sterilization

[18257200063413]

Moist Heat or Steam Sterilization

[18257200063413]

Moist Heat or Steam Sterilization

[18257200063413]

Moist Heat or Steam Sterilization

[18257200063413]

Moist Heat or Steam Sterilization

[18257200063413]

Moist Heat or Steam Sterilization

[18257200063413]

Moist Heat or Steam Sterilization

[18257200063413]

Moist Heat or Steam Sterilization

[18257200063413]

Moist Heat or Steam Sterilization

[18257200063413]

Moist Heat or Steam Sterilization

[18257200063413]

Moist Heat or Steam Sterilization

[18257200063413]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-27
• Device Publish Date: 2019-03-19

On-Brand Devices [ASCENT;ASCENT LE;CENTURION]

• 18257200063413: CROSS CONNECTOR TORQUE LIMITING DRIVER
• 18257200063406: CROSS CONNECTOR SET SCREW DRIVER