HAnano InterFuse 9076-11-20-5-B-HA

GUDID 00840314193605

Expansion Module B 11x20, 5°

NEXT ORTHOSURGICAL, INC.

Vertebral body prosthesis

• Primary Device ID: 00840314193605
• NIH Device Record Key: f3923d3f-228b-4366-8be0-c6e31aa29b5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAnano InterFuse
• Version Model Number: 9076-11-20-5-B-HA
• Catalog Number: 9076-11-20-5-B-HA
• Company DUNS: 046767258
• Company Name: NEXT ORTHOSURGICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 760-295-3600
• Email: Info@nextorthosurgical.com
• Phone: 760-295-3600
• Email: Info@nextorthosurgical.com
• Phone: 760-295-3600
• Email: Info@nextorthosurgical.com
• Phone: 760-295-3600
• Email: Info@nextorthosurgical.com

Device Dimensions

• Length: 20 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Angle: 5 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840314193605 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242509

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-19
• Device Publish Date: 2024-11-11

On-Brand Devices [HAnano InterFuse]

• 00840314193636: Expansion Module B 14x20, 5°
• 00840314193629: Expansion Module B 13x20, 5°
• 00840314193612: Expansion Module B 12x20, 5°
• 00840314193605: Expansion Module B 11x20, 5°
• 00840314193599: Expansion Module B 10x20, 5°
• 00840314193582: Expansion Module B 9x20, 5°
• 00840314193575: Expansion Module B 8x20, 5°
• 00840314193568: Expansion Module B 7x20, 5°
• 00840314193551: Expansion Module B 14x20, 0°
• 00840314193544: Expansion Module B 13x20, 0°
• 00840314193537: Expansion Module B 12x20, 0°
• 00840314193520: Expansion Module B 11x20, 0°
• 00840314193513: Expansion Module B 10x20, 0°
• 00840314193506: Expansion Module B 9x20, 0°
• 00840314193490: Expansion Module B 8x20, 0°
• 00840314193483: Expansion Module B 7x20, 0°
• 00840314193476: Modular Interbody Kit 14x20, 5°
• 00840314193469: Modular Interbody Kit 13x20, 5°
• 00840314193452: Modular Interbody Kit 12x20, 5°
• 00840314193445: Modular Interbody Kit 11x20, 5°
• 00840314193438: Modular Interbody Kit 10x20, 5°
• 00840314193421: Modular Interbody Kit 9x20, 5°
• 00840314193414: Modular Interbody Kit 8x20, 5°
• 00840314193407: Modular Interbody Kit 7x20, 5°
• 00840314193391: Modular Interbody Kit 14x20, 0°
• 00840314193384: Modular Interbody Kit 13x20, 0°
• 00840314193377: Modular Interbody Kit 12x20, 0°
• 00840314193360: Modular Interbody Kit 11x20, 0°
• 00840314193353: Modular Interbody Kit 10x20, 0°
• 00840314193346: Modular Interbody Kit 9x20, 0°
• 00840314193339: Modular Interbody Kit 8x20, 0°
• 00840314193322: Modular Interbody Kit 7x20, 0°