PILLAR PL;CONSTRUX - PEEK VBR

GUDID 18257200039234

PILLAR PL SPACER 9X23X16 PARALLEL

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: 18257200039234
• NIH Device Record Key: a8db53e0-4ac2-4de4-86b8-ba18e2279348
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PILLAR PL;CONSTRUX - PEEK VBR
• Version Model Number: 45-6216
• 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	18257200039234 [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

[18257200039234]

Moist Heat or Steam Sterilization

[18257200039234]

Moist Heat or Steam Sterilization

[18257200039234]

Moist Heat or Steam Sterilization

[18257200039234]

Moist Heat or Steam Sterilization

[18257200039234]

Moist Heat or Steam Sterilization

[18257200039234]

Moist Heat or Steam Sterilization

[18257200039234]

Moist Heat or Steam Sterilization

[18257200039234]

Moist Heat or Steam Sterilization

[18257200039234]

Moist Heat or Steam Sterilization

[18257200039234]

Moist Heat or Steam Sterilization

[18257200039234]

Moist Heat or Steam Sterilization

[18257200039234]

Moist Heat or Steam Sterilization

[18257200039234]

Moist Heat or Steam Sterilization

[18257200039234]

Moist Heat or Steam Sterilization

[18257200039234]

Moist Heat or Steam Sterilization

[18257200039234]

Moist Heat or Steam Sterilization

[18257200039234]

Moist Heat or Steam Sterilization

[18257200039234]

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