LONESTAR

GUDID 18257200091058

7° IMPLANT- 15 X 15 X 10

ORTHOFIX INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 18257200091058
• NIH Device Record Key: bb53d61f-bcf6-4835-bf72-ede9b3c03d04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LONESTAR
• Version Model Number: 83-5510
• 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	18257200091058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161280

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, cervical

Sterilization

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

[18257200091058]

Moist Heat or Steam Sterilization

[18257200091058]

Moist Heat or Steam Sterilization

[18257200091058]

Moist Heat or Steam Sterilization

[18257200091058]

Moist Heat or Steam Sterilization

[18257200091058]

Moist Heat or Steam Sterilization

[18257200091058]

Moist Heat or Steam Sterilization

[18257200091058]

Moist Heat or Steam Sterilization

[18257200091058]

Moist Heat or Steam Sterilization

[18257200091058]

Moist Heat or Steam Sterilization

[18257200091058]

Moist Heat or Steam Sterilization

[18257200091058]

Moist Heat or Steam Sterilization

[18257200091058]

Moist Heat or Steam Sterilization

[18257200091058]

Moist Heat or Steam Sterilization

[18257200091058]

Moist Heat or Steam Sterilization

[18257200091058]

Moist Heat or Steam Sterilization

[18257200091058]

Moist Heat or Steam Sterilization

[18257200091058]

Moist Heat or Steam Sterilization

[18257200091058]

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 [LONESTAR]

• 18257200124008: LONESTAR - RASP CASE
• 18257200123995: LONESTAR - LEVEL, RASP CASE
• 18257200123988: LONESTAR - LID, RASP CASE
• 18257200118540: LONESTAR - BOTTOM LEVEL, IMPLANT / INSTRUMENT CASE
• 18257200118533: LONESTAR - MIDDLE LEVEL, IMPLANT / INSTRUMENT CASE
• 18257200118526: LONESTAR - TOP LEVEL, IMPLANT / INSTRUMENT CASE
• 18257200118519: LONESTAR - LID, IMPLANT / INSTRUMENT CASE
• 18257200118502: LONESTAR - SERRATED RADIAL RIBS - IMPLANT CADDY KIT (83-9106)
• 18257200118496: LONESTAR - INSTRUMENT TRAY KIT (83-9000)
• 18257200118489: LONESTAR - IMPLANT CADDY
• 18257200115860: 0° IMPLANT, SERRATED RADIAL RIBS, 17 X 15 X 14
• 18257200115853: 0° IMPLANT, SERRATED RADIAL RIBS, 17 X 15 X 13
• 18257200115846: 0° IMPLANT, SERRATED RADIAL RIBS, 17 X 15 X 12
• 18257200115839: 0° IMPLANT, SERRATED RADIAL RIBS, 17 X 15 X 11
• 18257200115822: 0° IMPLANT, SERRATED RADIAL RIBS, 17 X 15 X 10
• 18257200115815: 0° IMPLANT, SERRATED RADIAL RIBS, 17 X 15 X 9
• 18257200115808: 0° IMPLANT, SERRATED RADIAL RIBS, 17 X 15 X 8
• 18257200115792: 0° IMPLANT, SERRATED RADIAL RIBS, 17 X 15 X 7
• 18257200115785: 0° IMPLANT, SERRATED RADIAL RIBS, 17 X 15 X 6
• 18257200115778: 7° IMPLANT, SERRATED RADIAL RIBS, 17 X 15 X 14
• 18257200115761: 7° IMPLANT, SERRATED RADIAL RIBS, 17 X 15 X 13
• 18257200115754: 7° IMPLANT, SERRATED RADIAL RIBS, 17 X 15 X 12
• 18257200115747: 7° IMPLANT, SERRATED RADIAL RIBS, 17 X 15 X 11
• 18257200115730: 7° IMPLANT, SERRATED RADIAL RIBS, 17 X 15 X 10
• 18257200115723: 7° IMPLANT, SERRATED RADIAL RIBS, 17 X 15 X 9
• 18257200115716: 7° IMPLANT, SERRATED RADIAL RIBS, 17 X 15 X 8
• 18257200115709: 7° IMPLANT, SERRATED RADIAL RIBS, 17 X 15 X 7
• 18257200115693: 7° IMPLANT, SERRATED RADIAL RIBS, 17 X 15 X 6
• 18257200115686: 0° IMPLANT, SERRATED RADIAL RIBS, 17 X 13 X 14
• 18257200115679: 0° IMPLANT, SERRATED RADIAL RIBS, 17 X 13 X 13
• 18257200115662: 0° IMPLANT, SERRATED RADIAL RIBS, 17 X 13 X 12
• 18257200115655: 0° IMPLANT, SERRATED RADIAL RIBS, 17 X 13 X 11
• 18257200115648: 0° IMPLANT, SERRATED RADIAL RIBS, 17 X 13 X 10
• 18257200115631: 0° IMPLANT, SERRATED RADIAL RIBS, 17 X 13 X 9
• 18257200115624: 0° IMPLANT, SERRATED RADIAL RIBS, 17 X 13 X 8
• 18257200115617: 0° IMPLANT, SERRATED RADIAL RIBS, 17 X 13 X 7
• 18257200115600: 0° IMPLANT, SERRATED RADIAL RIBS, 17 X 13 X 6
• 18257200115594: 7° IMPLANT, SERRATED RADIAL RIBS, 17 X 13 X 14
• 18257200115587: 7° IMPLANT, SERRATED RADIAL RIBS, 17 X 13 X 13
• 18257200115570: 7° IMPLANT, SERRATED RADIAL RIBS, 17 X 13 X 12
• 18257200115563: 7° IMPLANT, SERRATED RADIAL RIBS, 17 X 13 X 11
• 18257200115556: 7° IMPLANT, SERRATED RADIAL RIBS, 17 X 13 X 10
• 18257200115549: 7° IMPLANT, SERRATED RADIAL RIBS, 17 X 13 X 9
• 18257200115532: 7° IMPLANT, SERRATED RADIAL RIBS, 17 X 13 X 8
• 18257200115525: 7° IMPLANT, SERRATED RADIAL RIBS, 17 X 13 X 7
• 18257200115518: 7° IMPLANT, SERRATED RADIAL RIBS, 17 X 13 X 6
• 18257200115501: 0° IMPLANT, SERRATED RADIAL RIBS, 15 X 15 X 14
• 18257200115495: 0° IMPLANT, SERRATED RADIAL RIBS, 15 X 15 X 13
• 18257200115488: 0° IMPLANT, SERRATED RADIAL RIBS, 15 X 15 X 12
• 18257200115471: 0° IMPLANT, SERRATED RADIAL RIBS, 15 X 15 X 11