PILLAR PL;CONSTRUX - PEEK VBR

GUDID 18257200039197

PILLAR PL SPACER 9X23X12 PARALLEL

ORTHOFIX INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 18257200039197
• NIH Device Record Key: 3e5084a2-9a3d-4b10-8f91-2f89894d12e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PILLAR PL;CONSTRUX - PEEK VBR
• Version Model Number: 45-6212
• 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	18257200039197 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082235

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[18257200039197]

Moist Heat or Steam Sterilization

[18257200039197]

Moist Heat or Steam Sterilization

[18257200039197]

Moist Heat or Steam Sterilization

[18257200039197]

Moist Heat or Steam Sterilization

[18257200039197]

Moist Heat or Steam Sterilization

[18257200039197]

Moist Heat or Steam Sterilization

[18257200039197]

Moist Heat or Steam Sterilization

[18257200039197]

Moist Heat or Steam Sterilization

[18257200039197]

Moist Heat or Steam Sterilization

[18257200039197]

Moist Heat or Steam Sterilization

[18257200039197]

Moist Heat or Steam Sterilization

[18257200039197]

Moist Heat or Steam Sterilization

[18257200039197]

Moist Heat or Steam Sterilization

[18257200039197]

Moist Heat or Steam Sterilization

[18257200039197]

Moist Heat or Steam Sterilization

[18257200039197]

Moist Heat or Steam Sterilization

[18257200039197]

Moist Heat or Steam Sterilization

[18257200039197]

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: 2019-03-19

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

• 18257200039234: PILLAR PL SPACER 9X23X16 PARALLEL
• 18257200039227: PILLAR PL SPACER 9X23X15 PARALLEL
• 18257200039210: PILLAR PL SPACER 9X23X14 PARALLEL
• 18257200039203: PILLAR PL SPACER 9X23X13 PARALLEL
• 18257200039197: PILLAR PL SPACER 9X23X12 PARALLEL
• 18257200039180: PILLAR PL SPACER 9X23X11 PARALLEL
• 18257200039173: PILLAR PL SPACER 9X23X10 PARALLEL
• 18257200039166: PILLAR PL SPACER 9X23X9 PARALLEL
• 18257200039159: PILLAR PL SPACER 9X23X8 PARALLEL