Anterior Lumbar Interbody Fusion System

GUDID 00814008020126

25x34 10mm 12 Degree

NVISION BIOMEDICAL TECHNOLOGIES, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00814008020126
• NIH Device Record Key: 3b2c5083-ac53-499b-a6cb-618720f0397d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anterior Lumbar Interbody Fusion System
• Version Model Number: AL-1210-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	00814008020126 [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

[00814008020126]

Moist Heat or Steam Sterilization

[00814008020126]

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 [Anterior Lumbar Interbody Fusion System]

• 00814008020232: 29x39 20mm 12 Degree
• 00814008020225: 29x39 18mm 12 Degree
• 00814008020218: 29x39 16mm 12 degree
• 00814008020201: 29x39 14mm 12 Degree
• 00814008020195: 29x39 12mm 12 Degree
• 00814008020188: 29x39 10mm 12 Degree
• 00814008020171: 25x34 20mm 12 Degree
• 00814008020164: 25x34 18mm 12 Degree
• 00814008020157: 25x34 16mm 12 Degree
• 00814008020140: 25x34 14mm 12 Degree
• 00814008020133: 25x34 12mm 12 Degree
• 00814008020126: 25x34 10mm 12 Degree
• 00814008020119: 29x39 20mm 6 Degree
• 00814008020102: 29x39 18mm 6 Degree
• 00814008020096: 29x39 16mm 6 Degree
• 00814008020089: 29x39 14mm 6 Degree
• 00814008020072: 29x39 12mm 6 Degree
• 00814008020065: 29x39 10mm 6 Degree
• 00814008020058: 25x34 20mm 6 Degree
• 00814008020041: 25x34 18mm 6 Degree
• 00814008020034: 25x34 16mm 6 Degree
• 00814008020027: 25x34 14mm 6 Degree