TLIF - Transforaminal Lumbar Interbody Fusion System

GUDID 00814008021871

11x35 13mm 0 Degrees

NVISION BIOMEDICAL TECHNOLOGIES, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00814008021871
• NIH Device Record Key: 25146a99-b556-475c-ba5f-a0970331afef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TLIF - Transforaminal Lumbar Interbody Fusion System
• Version Model Number: TL-013-T
• 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: 11 Millimeter
• Length: 11 Millimeter
• Length: 11 Millimeter
• Length: 11 Millimeter
• Length: 11 Millimeter
• Length: 11 Millimeter
• Length: 11 Millimeter
• Length: 11 Millimeter
• Length: 11 Millimeter
• Length: 11 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814008021871 [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

[00814008021871]

Moist Heat or Steam Sterilization

[00814008021871]

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 [TLIF - Transforaminal Lumbar Interbody Fusion System]

• 00814008021987: 11x35 15mm 7 Degree
• 00814008021970: 11x35 14mm 7 Degree
• 00814008021963: 11x35 13mm 7 Degree
• 00814008021956: 11x35 12mm 7 Degree
• 00814008021949: 11x35 11mm 7 Degree
• 00814008021932: 11x35 10mm 7 Degree
• 00814008021925: 11x35 9mm 7 Degrees
• 00814008021918: 11x35 8mm 7 Degrees
• 00814008021901: 11x35 7mm 7 Degrees
• 00814008021895: 11x35 15mm 0 Degrees
• 00814008021888: 11x35 14mm 0 Degrees
• 00814008021871: 11x35 13mm 0 Degrees
• 00814008021864: 11x35 12mm 0 Degrees
• 00814008021857: 11x35 11mm 0 Degrees
• 00814008021840: 11x35 10mm 0 Degrees
• 00814008021833: 11x35 9mm 0 Degrees
• 00814008021826: 11x35 8mm 0 Degrees
• 00814008021819: 11x35 7mm 0 Degrees
• 00814008021802: 11x35 6mm 0 Degrees