CONSTRUX - PEEK VBR;PILLAR AL 48-0020

GUDID 18257200081394

PILLAR AL INST (48-0020)

ORTHOFIX INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 18257200081394
• NIH Device Record Key: 9f13c9c8-5b5b-4242-8440-4ddb8c32683b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONSTRUX - PEEK VBR;PILLAR AL
• Version Model Number: 450218-0001
• Catalog Number: 48-0020
• 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: false
• 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	18257200081394 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082235

FDA Product Code

• MQP: Spinal vertebral body replacement device

Sterilization

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

[18257200081394]

Moist Heat or Steam Sterilization

[18257200081394]

Moist Heat or Steam Sterilization

[18257200081394]

Moist Heat or Steam Sterilization

[18257200081394]

Moist Heat or Steam Sterilization

[18257200081394]

Moist Heat or Steam Sterilization

[18257200081394]

Moist Heat or Steam Sterilization

[18257200081394]

Moist Heat or Steam Sterilization

[18257200081394]

Moist Heat or Steam Sterilization

[18257200081394]

Moist Heat or Steam Sterilization

[18257200081394]

Moist Heat or Steam Sterilization

[18257200081394]

Moist Heat or Steam Sterilization

[18257200081394]

Moist Heat or Steam Sterilization

[18257200081394]

Moist Heat or Steam Sterilization

[18257200081394]

Moist Heat or Steam Sterilization

[18257200081394]

Moist Heat or Steam Sterilization

[18257200081394]

Moist Heat or Steam Sterilization

[18257200081394]

Moist Heat or Steam Sterilization

[18257200081394]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-03-12

On-Brand Devices [CONSTRUX - PEEK VBR;PILLAR AL]

• 18257200081394: PILLAR AL INST (48-0020)
• 18257200042401: PILLAR AL BONE PACKER
• 18257200042395: PILLAR AL TAMP