PILLAR SA PTC

GUDID 18257200112661

33W X 28L X 18H, 7DEG PTC IMPLANT STERILE

ORTHOFIX INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 18257200112661
• NIH Device Record Key: 46944b38-0e83-43d9-b294-f488474d015b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PILLAR SA PTC
• Version Model Number: 39-9018SP
• 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	18257200112661 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172437

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[18257200112661]

Moist Heat or Steam Sterilization

[18257200112661]

Moist Heat or Steam Sterilization

[18257200112661]

Moist Heat or Steam Sterilization

[18257200112661]

Moist Heat or Steam Sterilization

[18257200112661]

Moist Heat or Steam Sterilization

[18257200112661]

Moist Heat or Steam Sterilization

[18257200112661]

Moist Heat or Steam Sterilization

[18257200112661]

Moist Heat or Steam Sterilization

[18257200112661]

Moist Heat or Steam Sterilization

[18257200112661]

Moist Heat or Steam Sterilization

[18257200112661]

Moist Heat or Steam Sterilization

[18257200112661]

Moist Heat or Steam Sterilization

[18257200112661]

Moist Heat or Steam Sterilization

[18257200112661]

Moist Heat or Steam Sterilization

[18257200112661]

Moist Heat or Steam Sterilization

[18257200112661]

Moist Heat or Steam Sterilization

[18257200112661]

Moist Heat or Steam Sterilization

[18257200112661]

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 [PILLAR SA PTC]

• 18257200112869: 40W X 28L X 18H, 12DEG PTC IMPLANT STERILE
• 18257200112852: 40W X 28L X 16H, 12DEG PTC IMPLANT STERILE
• 18257200112845: 40W X 28L X 14H, 12DEG PTC IMPLANT STERILE
• 18257200112838: 40W X 28L X 12.5H, 12DEG PTC IMPLANT STERILE
• 18257200112821: 40W X 28L X 18H, 7DEG PTC IMPLANT STERILE
• 18257200112814: 40W X 28L X 16H, 7DEG PTC IMPLANT STERILE
• 18257200112807: 40W X 28L X 14H, 7DEG PTC IMPLANT STERILE
• 18257200112791: 40W X 28L X 12.5H, 7DEG PTC IMPLANT STERILE
• 18257200112784: 37W X 28L X 18H, 12DEG PTC IMPLANT STERILE
• 18257200112777: 37W X 28L X 16H, 12DEG PTC IMPLANT STERILE
• 18257200112760: 37W X 28L X 14H, 12DEG PTC IMPLANT STERILE
• 18257200112753: 37W X 28L X 12.5H, 12DEG PTC IMPLANT STERILE
• 18257200112746: 37W X 28L X 18H, 7DEG PTC IMPLANT STERILE
• 18257200112739: 37W X 28L X 16H, 7DEG PTC IMPLANT STERILE
• 18257200112722: 37W X 28L X 14H, 7DEG PTC IMPLANT STERILE
• 18257200112715: 37W X 28L X 12.5H, 7DEG PTC IMPLANT STERILE
• 18257200112708: 33W X 28L X 18H, 12DEG PTC IMPLANT STERILE
• 18257200112692: 33W X 28L X 16H, 12DEG PTC IMPLANT STERILE
• 18257200112685: 33W X 28L X 14H, 12DEG PTC IMPLANT STERILE
• 18257200112678: 33W X 28L X 12.5H, 12DEG PTC IMPLANT STERILE
• 18257200112661: 33W X 28L X 18H, 7DEG PTC IMPLANT STERILE
• 18257200112654: 33W X 28L X 16H, 7DEG PTC IMPLANT STERILE
• 18257200112647: 33W X 28L X 14H, 7DEG PTC IMPLANT STERILE
• 18257200112630: 33W X 28L X 12.5H, 7DEG PTC IMPLANT STERILE