nvt

GUDID 90814008025179

TLIF Encoded 11x35 11mm 0 Degrees

NVISION BIOMEDICAL TECHNOLOGIES, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 90814008025179
• NIH Device Record Key: 3ed02128-a89b-48e9-9ea7-b4b510079826
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: nvt
• Version Model Number: TLE-011-T
• Company DUNS: 047486041
• Company Name: NVISION BIOMEDICAL TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	90814008025179 [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

[90814008025179]

Moist Heat or Steam Sterilization

[90814008025179]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-02-24
• Device Publish Date: 2017-05-15

On-Brand Devices [nvt]

• 00814008022212: Caddy Base for TLIF implants, Transforaminal Lumbar Interbody Fusion System (TLIF)
• 00814008022205: Instrument, Trial, Transforaminal Lumbar Interbody Fusion System (TLIF)
• 00814008022199: Instrument, Trial, Transforaminal Lumbar Interbody Fusion System (TLIF)
• 00814008022182: Instrument, Trial, Transforaminal Lumbar Interbody Fusion System (TLIF)
• 00814008022175: Instrument, Trial, Transforaminal Lumbar Interbody Fusion System (TLIF)
• 00814008022168: Instrument, Trial, Transforaminal Lumbar Interbody Fusion System (TLIF)
• 00814008022151: Instrument, Trial, Transforaminal Lumbar Interbody Fusion System (TLIF)
• 00814008022144: Instrument, Trial, Transforaminal Lumbar Interbody Fusion System (TLIF)
• 00814008022137: Instrument, Trial, Transforaminal Lumbar Interbody Fusion System (TLIF)
• 00814008022120: Instrument, Trial, Transforaminal Lumbar Interbody Fusion System (TLIF)
• 00814008022113: Instrument, Trial, Transforaminal Lumbar Interbody Fusion System (TLIF)
• 00814008022106: Instrument, Trial, Transforaminal Lumbar Interbody Fusion System (TLIF)
• 00814008022090: Instrument, Trial, Transforaminal Lumbar Interbody Fusion System (TLIF)
• 00814008022083: Instrument, Trial, Transforaminal Lumbar Interbody Fusion System (TLIF)
• 00814008022076: Instrument, Trial, Transforaminal Lumbar Interbody Fusion System (TLIF)
• 00814008022069: Instrument, Trial, Transforaminal Lumbar Interbody Fusion System (TLIF)
• 00814008022052: Instrument, Trial, Transforaminal Lumbar Interbody Fusion System (TLIF)
• 00814008022045: Instrument, Trial, Transforaminal Lumbar Interbody Fusion System (TLIF)
• 00814008022038: Instrument, Trial, Transforaminal Lumbar Interbody Fusion System (TLIF)
• 00814008022021: Instrument, Trial, Transforaminal Lumbar Interbody Fusion System (TLIF)
• 00814008021994: Instrument, Curved Inserter, Transforaminal Lumbar Interbody Fusion System (TLIF)
• 90814008025308: TLIF Encoded 11x35 15mm 7 Degree
• 90814008025292: TLIF Encoded 11x35 14mm 7 Degree
• 90814008025285: TLIF Encoded 11x35 13mm 7 Degree
• 90814008025278: TLIF Encoded 11x35 12mm 7 Degree
• 90814008025261: TLIF Encoded 11x35 11mm 7 Degree
• 90814008025254: TLIF Encoded 11x35 10mm 7 Degree
• 90814008025247: TLIF Encoded 11x35 9mm 7 Degrees
• 90814008025230: TLIF Encoded 11x35 8mm 7 Degrees
• 90814008025223: TLIF Encoded 11x35 7mm 7 Degrees
• 90814008025216: TLIF Encoded 11x35 15mm 0 Degrees
• 90814008025209: TLIF Encoded 11x35 14mm 0 Degrees
• 90814008025193: TLIF Encoded 11x35 13mm 0 Degrees
• 90814008025186: TLIF Encoded 11x35 12mm 0 Degrees
• 90814008025179: TLIF Encoded 11x35 11mm 0 Degrees
• 90814008025162: TLIF Encoded 11x35 10mm 0 Degrees
• 90814008025155: TLIF Encoded 11x35 9mm 0 Degrees
• 90814008025148: TLIF Encoded 11x35 8mm 0 Degrees
• 90814008025131: TLIF Encoded 11x35 7mm 0 Degrees
• 90814008025124: TLIF Encoded 11x35 6mm 0 Degrees