PILLAR AL

GUDID 18257200043309

PILLAR AL SPACER 30X24X10 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: 18257200043309
• NIH Device Record Key: df532dd7-484e-4c54-ac40-d65fddfa84d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PILLAR AL
• Version Model Number: 48-3010
• 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	18257200043309 [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

[18257200043309]

Moist Heat or Steam Sterilization

[18257200043309]

Moist Heat or Steam Sterilization

[18257200043309]

Moist Heat or Steam Sterilization

[18257200043309]

Moist Heat or Steam Sterilization

[18257200043309]

Moist Heat or Steam Sterilization

[18257200043309]

Moist Heat or Steam Sterilization

[18257200043309]

Moist Heat or Steam Sterilization

[18257200043309]

Moist Heat or Steam Sterilization

[18257200043309]

Moist Heat or Steam Sterilization

[18257200043309]

Moist Heat or Steam Sterilization

[18257200043309]

Moist Heat or Steam Sterilization

[18257200043309]

Moist Heat or Steam Sterilization

[18257200043309]

Moist Heat or Steam Sterilization

[18257200043309]

Moist Heat or Steam Sterilization

[18257200043309]

Moist Heat or Steam Sterilization

[18257200043309]

Moist Heat or Steam Sterilization

[18257200043309]

Moist Heat or Steam Sterilization

[18257200043309]

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 AL]

• 18257200043743: PILLAR AL SPACER 34X28X22, 12DEG LORDOTIC
• 18257200043736: PILLAR AL SPACER 34X28X22, 12DEG LORDOTIC
• 18257200043729: PILLAR AL SPACER 34X28X20, 12DEG LORDOTIC
• 18257200043712: PILLAR AL SPACER 34X28X18, 12DEG LORDOTIC
• 18257200043705: PILLAR AL SPACER 34X28X16, 12DEG LORDOTIC
• 18257200043699: PILLAR AL SPACER 34X28X14, 12DEG LORDOTIC
• 18257200043682: PILLAR AL SPACER 34X28X12, 12DEG LORDOTIC
• 18257200043675: PILLAR AL SPACER 34X28X22, 7DEG LORDOTIC
• 18257200043668: PILLAR AL SPACER 34X28X20, 7DEG LORDOTIC
• 18257200043651: PILLAR AL SPACER 34X28X18, 7DEG LORDOTIC
• 18257200043644: PILLAR AL SPACER 34X28X16, 7DEG LORDOTIC
• 18257200043637: PILLAR AL SPACER 34X28X14, 7DEG LORDOTIC
• 18257200043620: PILLAR AL SPACER 34X28X12, 7DEG LORDOTIC
• 18257200043613: PILLAR AL SPACER 34X28X10, 7DEG LORDOTIC
• 18257200043606: PILLAR AL 20MM 0DEG 34MM X 28MM, 0DEG
• 18257200043590: PILLAR AL 18MM 0DEG 34MM X 28MM, 0DEG
• 18257200043583: PILLAR AL 16MM 0DEG 34MM X 28MM, 0DEG
• 18257200043576: PILLAR AL 14MM 0DEG 34MM X 28MM, 0DEG
• 18257200043569: PILLAR AL 12MM 0DEG 34MM X 28MM, 0DEG
• 18257200043552: PILLAR AL 10MM 0DEG 34MM X 28MM, 0DEG
• 18257200043545: PILLAR AL 8MM 0DEG 34MM X 28MM, 0DEG
• 18257200043491: PILLAR AL SPACER 30X24X24, 12DEG LORDOTIC
• 18257200043484: PILLAR AL SPACER 30X24X22, 12DEG LORDOTIC
• 18257200043477: PILLAR AL SPACER 30X24X20, 12DEG LORDOTIC
• 18257200043460: PILLAR AL SPACER 30X24X18, 12DEG LORDOTIC
• 18257200043453: PILLAR AL SPACER 30X24X16, 12DEG LORDOTIC
• 18257200043446: PILLAR AL SPACER 30X24X14, 12DEG LORDOTIC
• 18257200043439: PILLAR AL SPACER 30X24X12, 12DEG LORDOTIC
• 18257200043415: PILLAR AL SPACER 30X24X 22, 7DEG LORDOTIC
• 18257200043408: PILLAR AL SPACER 30X24X20, 7DEG LORDOTIC
• 18257200043392: PILLAR AL SPACER 30X24X18, 7DEG LORDOTIC
• 18257200043385: PILLAR AL SPACER 30X24X16, 7DEG LORDOTIC
• 18257200043378: PILLAR AL SPACER 30X24X14, 7DEG LORDOTIC
• 18257200043361: PILLAR AL SPACER 30X24X12, 7DEG LORDOTIC
• 18257200043354: PILLAR AL SPACER 30X24X10, 7DEG LORDOTIC
• 18257200043347: PILLAR AL SPACER 30X24X18 PARALLEL
• 18257200043330: PILLAR AL SPACER 30X24X16 PARALLEL
• 18257200043323: PILLAR AL SPACER 30X24X14 PARALLEL
• 18257200043316: PILLAR AL SPACER 30X24X12 PARALLEL
• 18257200043309: PILLAR AL SPACER 30X24X10 PARALLEL
• 18257200043293: PILLAR AL SPACER 30X24X8 PARALLEL
• 18257200043286: PILLAR AL 24MM X 12DEG 26MM X 20MM, 12DEG LORDOTIC
• 18257200043279: PILLAR AL 22MM X 12DEG 26MM X 20MM, 12DEG LORDOTIC
• 18257200043262: PILLAR AL 20MM X 12DEG 26MM X 20MM, 12DEG LORDOTIC
• 18257200043255: PILLAR AL 18MM X 12DEG 26MM X 20MM, 12DEG LORDOTIC
• 18257200043248: PILLAR AL 16MM X 12DEG 26MM X 20MM, 12DEG LORDOTIC
• 18257200043231: PILLAR AL 14MM X 12DEG 26MM X 20MM, 12DEG LORDOTIC
• 18257200043224: PILLAR AL 12MM X 12DEG 26MM X 20MM, 12DEG LORDOTIC
• 18257200043217: PILLAR AL 10MM X 12DEG 26MM X 20MM, 12DEG LORDOTIC
• 18257200043200: PILLAR AL SPACER 26X20X20, 7DEG LORDOTIC