ALIF Anterior Lumbar Interbody Fusion System

GUDID 00814008020003

25x34 10mm 6 Degree

NVISION BIOMEDICAL TECHNOLOGIES, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00814008020003
• NIH Device Record Key: 85136585-faba-490b-8628-251f53eb03fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALIF Anterior Lumbar Interbody Fusion System
• Version Model Number: AL-0610-S
• 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: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814008020003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142594

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00814008020003]

Moist Heat or Steam Sterilization

[00814008020003]

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

Devices Manufactured by NVISION BIOMEDICAL TECHNOLOGIES, INC.

• 00810005665179 - Boundary: 2024-08-16 Buttress Plate Screw 20mm long, 5.5mm circumference, non locking, cancellous. The Boundary Anterior Lumbar Buttress Plate is in
• 00810005665186 - Boundary: 2024-08-16 Buttress Plate Screw 25mm long, 5.5mm circumference, non locking, cancellous. The Boundary Anterior Lumbar Buttress Plate is in
• 00810005665193 - Boundary: 2024-08-16 Buttress Plate Screw 30mm long, 5.5mm circumference, non locking, cancellous. The Boundary Anterior Lumbar Buttress Plate is in
• 00810005665209 - Boundary: 2024-08-16 Buttress Plate Screw 35mm long, 5.5mm circumference, non locking, cancellous. The Boundary Anterior Lumbar Buttress Plate is in
• 00810005665216 - Boundary: 2024-08-16 Buttress Plate Screw 20mm long, 5.5mm circumference, locking, cancellous. The Boundary Anterior Lumbar Buttress Plate is intend
• 00810005665223 - Boundary: 2024-08-16 Buttress Plate Screw 30mm long, 5.5mm circumference, locking, cancellous. The Boundary Anterior Lumbar Buttress Plate is intend
• 00810005665230 - Boundary: 2024-08-16 Buttress Plate Screw 25mm long, 5.5mm circumference, locking, cancellous. The Boundary Anterior Lumbar Buttress Plate is intend
• 00810005665247 - Boundary: 2024-08-16 Buttress Plate Screw 35mm long, 5.5mm circumference, locking, cancellous. The Boundary Anterior Lumbar Buttress Plate is intend