ACIF - Anterior Cervical Interbody Fusion System

GUDID 00814008022465

14X16 11mm 0 Degree

NVISION BIOMEDICAL TECHNOLOGIES, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00814008022465
• NIH Device Record Key: 5e4835df-6ed5-4dbc-9ee4-e7499cd5a4f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACIF - Anterior Cervical Interbody Fusion System
• Version Model Number: AC-011-L
• Company DUNS: 047486041
• Company Name: NVISION BIOMEDICAL TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com

Device Dimensions

• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814008022465 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142328

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[00814008022465]

Moist Heat or Steam Sterilization

[00814008022465]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-10-19

On-Brand Devices [ACIF - Anterior Cervical Interbody Fusion System]

• 00814008022557: 14X16 12mm 6 Degree
• 00814008022540: 14X16 11mm 6 Degree
• 00814008022533: 14X16 10mm 6 Degree
• 00814008022526: 14X16 9mm 6 Degree
• 00814008022519: 14X16 8mm 6 Degree
• 00814008022502: 14X16 7mm 6 Degree
• 00814008022496: 14X16 6mm 6 Degree
• 00814008022489: 14X16 5mm 6 Degree
• 00814008022472: 14X16 12mm 0 Degree
• 00814008022465: 14X16 11mm 0 Degree
• 00814008022458: 14X16 10mm 0 Degree
• 00814008022441: 14X16 9mm 0 Degree
• 00814008022434: 14X16 8mm 0 Degree
• 00814008022427: 14X16 7mm 0 Degree
• 00814008022410: 14X16 6mm 0 Degree
• 00814008022403: 14X16 5mm 0 Degree
• 00814008022397: 12X14 12mm 6 Degree
• 00814008022380: 12X14 11mm 6 Degree
• 00814008022373: 12X14 10mm 6 Degree
• 00814008022366: 12X14 9mm 6 Degree
• 00814008022359: 12X14 8mm 6 Degree
• 00814008022342: 12X14 7mm 6 Degree
• 00814008022335: 12X14 6mm 6 Degree
• 00814008022328: 12X14 5mm 6 Degree
• 00814008022311: 12X14 12mm 0 Degree
• 00814008022304: 12X14 11mm 0 Degree
• 00814008022298: 12X14 10mm 0 Degree
• 00814008022281: 12X14 9mm 0 Degree
• 00814008022274: 12X14 8mm 0 Degree
• 00814008022267: 12X14 7mm 0 Degree
• 00814008022250: 12X14 6mm 0 Degree
• 00814008022243: 12X14 5mm 0 Degree