RELIANT

GUDID 18257200062928

86MM THREE LEVEL CERVICAL PLATE ASSEMBLY, RELIANT ACPS

ORTHOFIX INC.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 18257200062928
• NIH Device Record Key: e741c864-9b87-4f61-9729-fd1205b7b4a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RELIANT
• Version Model Number: 64-6860
• 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
• 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	18257200062928 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030595

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

[18257200062928]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-27
• Device Publish Date: 2019-03-19

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• 18257200062706: 54MM TWO LEVEL CERVICAL PLATE ASSEMBLY, RELIANT ACPS
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• 18257200062652: 46MM TWO LEVEL CERVICAL PLATE ASSEMBLY, RELIANT ACPS
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