NGAGE

GUDID 18257200074075

NGAGE 6-LOBE 22X28MM, 35MM HEIGHT

ORTHOFIX INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 18257200074075
• NIH Device Record Key: 901aee9b-4dcb-41f0-92ae-dee916dbc798
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NGAGE
• Version Model Number: 76-2235
• 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	18257200074075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032700

FDA Product Code

• MQP: Spinal vertebral body replacement device

Sterilization

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

[18257200074075]

Moist Heat or Steam Sterilization

[18257200074075]

Moist Heat or Steam Sterilization

[18257200074075]

Moist Heat or Steam Sterilization

[18257200074075]

Moist Heat or Steam Sterilization

[18257200074075]

Moist Heat or Steam Sterilization

[18257200074075]

Moist Heat or Steam Sterilization

[18257200074075]

Moist Heat or Steam Sterilization

[18257200074075]

Moist Heat or Steam Sterilization

[18257200074075]

Moist Heat or Steam Sterilization

[18257200074075]

Moist Heat or Steam Sterilization

[18257200074075]

Moist Heat or Steam Sterilization

[18257200074075]

Moist Heat or Steam Sterilization

[18257200074075]

Moist Heat or Steam Sterilization

[18257200074075]

Moist Heat or Steam Sterilization

[18257200074075]

Moist Heat or Steam Sterilization

[18257200074075]

Moist Heat or Steam Sterilization

[18257200074075]

Moist Heat or Steam Sterilization

[18257200074075]

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 [NGAGE]

• 18257200081707: NGAGE IMPLANT (74-0005)
• 18257200081691: NGAGE INST (74-0006)
• 18257200074419: NGAGE 6-LOBE 26X33MM STANDARD RING
• 18257200074402: NGAGE 6-LOBE 22X28MM STANDARD RING
• 18257200074396: NGAGE 6-LOBE 17X22MM STANDARD RING
• 18257200074389: NGAGE 6-LOBE 13X17MM STANDARD RING
• 18257200074372: NGAGE 6-LOBE 12X15MM STANDARD RING
• 18257200074365: NGAGE 6-LOBE SCREW STANDARD RING
• 18257200074358: NGAGE 6-LOBE 5DEG ANGLED END CAP, 26MM
• 18257200074341: NGAGE 6-LOBE 5DEG ANGLED END CAP, 22MM
• 18257200074334: NGAGE 6-LOBE 5DEG ANGLED END CAP, 17MM
• 18257200074327: NGAGE 6-LOBE 5DEG ANGLED END CAP, 13MM
• 18257200074310: NGAGE 6-LOBE 5DEG ANGLED END CAP, 12MM
• 18257200074303: NGAGE 6-LOBE PARALLEL END CAP, 26MM
• 18257200074297: NGAGE 6-LOBE PARALLEL END CAP, 22MM
• 18257200074280: NGAGE 6-LOBE PARALLEL END CAP, 17MM
• 18257200074273: NGAGE 6-LOBE PARALLEL END CAP, 13MM
• 18257200074266: NGAGE 6-LOBE PARALLEL END CAP, 12MM
• 18257200074259: NGAGE 6-LOBE 26X33MM MESH, 90MM
• 18257200074242: NGAGE 6-LOBE 26X33MM, 80MM HEIGHT
• 18257200074235: NGAGE 6-LOBE 26X33MM MESH, 70MM
• 18257200074228: NGAGE 6-LOBE 26X33MM, 60MM HEIGHT
• 18257200074211: NGAGE 6-LOBE 26X33MM, 50MM HEIGHT
• 18257200074204: NGAGE 6-LOBE 26X33MM, 40MM HEIGHT
• 18257200074198: NGAGE 6-LOBE 26X33MM, 35MM HEIGHT
• 18257200074181: NGAGE 6-LOBE 26X33MM, 30MM HEIGHT
• 18257200074174: NGAGE 6-LOBE 26X33MM, 25MM HEIGHT
• 18257200074167: NGAGE 6-LOBE 26X33MM, 20MM HEIGHT
• 18257200074150: NGAGE 6-LOBE 26X33MM MESH, 15MM
• 18257200074143: NGAGE 6-LOBE 26X33MM MESH, 10MM
• 18257200074136: NGAGE 6-LOBE 22X28MM MESH, 90MM
• 18257200074129: NGAGE 6-LOBE 22X28MM, 80MM HEIGHT
• 18257200074112: NGAGE 6-LOBE 22X28MM MESH, 70MM
• 18257200074105: NGAGE 6-LOBE 22X28MM, 60MM HEIGHT
• 18257200074099: NGAGE 6-LOBE 22X28MM, 50MM HEIGHT
• 18257200074082: NGAGE 6-LOBE 22X28MM, 40MM HEIGHT
• 18257200074075: NGAGE 6-LOBE 22X28MM, 35MM HEIGHT
• 18257200074068: NGAGE 6-LOBE 22X28MM, 30MM HEIGHT
• 18257200074051: NGAGE 6-LOBE 22X28MM, 25MM HEIGHT
• 18257200074044: NGAGE 6-LOBE 22X28MM, 20MM HEIGHT
• 18257200074037: NGAGE 6-LOBE 22X28MM MESH, 15MM
• 18257200074020: NGAGE 6-LOBE 22X28MM MESH, 10MM
• 18257200074013: NGAGE 6-LOBE 17X22MM MESH, 90MM
• 18257200074006: NGAGE 6-LOBE 17X22MM, 80MM HEIGHT
• 18257200073993: NGAGE 6-LOBE 17X22MM MESH, 70MM
• 18257200073986: NGAGE 6-LOBE 17X22MM, 60MM HEIGHT
• 18257200073979: NGAGE 6-LOBE 17X22MM, 50MM HEIGHT
• 18257200073962: NGAGE 6-LOBE 17X22MM, 40MM HEIGHT
• 18257200073955: NGAGE 6-LOBE 17X22MM, 35MM HEIGHT
• 18257200073948: NGAGE 6-LOBE 17X22MM, 30MM HEIGHT