NGAGE

GUDID 18257200073139

NGAGE 4-LOBE 10MM, 20MM HEIGHT MESH

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: 18257200073139
• NIH Device Record Key: ed690711-851a-40cb-9cec-822d222eb82f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NGAGE
• Version Model Number: 74-1020
• 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	18257200073139 [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

[18257200073139]

Moist Heat or Steam Sterilization

[18257200073139]

Moist Heat or Steam Sterilization

[18257200073139]

Moist Heat or Steam Sterilization

[18257200073139]

Moist Heat or Steam Sterilization

[18257200073139]

Moist Heat or Steam Sterilization

[18257200073139]

Moist Heat or Steam Sterilization

[18257200073139]

Moist Heat or Steam Sterilization

[18257200073139]

Moist Heat or Steam Sterilization

[18257200073139]

Moist Heat or Steam Sterilization

[18257200073139]

Moist Heat or Steam Sterilization

[18257200073139]

Moist Heat or Steam Sterilization

[18257200073139]

Moist Heat or Steam Sterilization

[18257200073139]

Moist Heat or Steam Sterilization

[18257200073139]

Moist Heat or Steam Sterilization

[18257200073139]

Moist Heat or Steam Sterilization

[18257200073139]

Moist Heat or Steam Sterilization

[18257200073139]

Moist Heat or Steam Sterilization

[18257200073139]

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