ALIF - Anterior Lumbar Interbody Fusion System

GUDID 00814008020010

25x34 12mm 6 Degree

NVISION BIOMEDICAL TECHNOLOGIES, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00814008020010
• NIH Device Record Key: 92f8df9d-643a-4252-9269-1c66cf1d67fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALIF - Anterior Lumbar Interbody Fusion System
• Version Model Number: AL-0612-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	00814008020010 [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

[00814008020010]

Moist Heat or Steam Sterilization

[00814008020010]

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.

• 00810135963268 - Impact: 2025-10-02 PEEK Union Nail 3.0 countersink shaft The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation o
• 00810135963282 - Impact: 2025-10-02 PEEK Union Nail 4.0 Countersink Shaft The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation o
• 00810135963329 - Impact: 2025-10-02 PEEK Nail Cutter 4.0mm The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fracture
• 00810135963374 - Impact: 2025-10-02 PEEK Nail Cutter 3.0mm The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fracture
• 00810135963404 - Impact: 2025-10-02 Kwire Depth Gauge The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, os
• 00810135963411 - Impact: 2025-10-02 PEEK Nail Slap Hammer The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures
• 00810135963640 - Impact: 2025-10-02 Kwire 1.4mmx127mm single trocar The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone
• 00810135963657 - Impact: 2025-10-02 Mallet The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies,