CONSTRUX - PEEK VBR;PILLAR AL 48-0020

GUDID 18257200081394

PILLAR AL INST (48-0020)

ORTHOFIX INC.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage 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