nva

GUDID 90814008024622

ALIF Encoded 29x39 16mm 12 degree

NVISION BIOMEDICAL TECHNOLOGIES, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 90814008024622
• NIH Device Record Key: 4a4d7db9-79f9-4360-9492-5ec46773a916
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: nva
• Version Model Number: ALE-1216-L
• 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	90814008024622 [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

[90814008024622]

Moist Heat or Steam Sterilization

[90814008024622]

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 [nva]

• 00814008020621: Caddy Lid, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020591: Caddy Base for 29 X 39 implants, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020584: Caddy Base for 25 X 34 implants, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020560: ALIF Tray 1, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020557: ALIF Tray 2, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020553: Case Lid, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020546: Case Base, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020539: Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020522: Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020515: Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020508: Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020492: Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020485: Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020478: Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020461: Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020454: Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020447: Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020430: Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020423: Instrument, Trial Large, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020416: Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020409: Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020393: Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020386: Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020379: Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020362: Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020355: Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020348: Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020331: Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020324: Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020317: Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020300: Instrument, Trial Small, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020294: Instrument, Tamp Curved, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020287: Instrument, Rasp Distractor Tip - Small, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020270: Instrument, Distractor Tip - Small, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020263: Instrument, Parallel Distractor, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020256: Instrument, Trans-anterior Inserter Shaft, Anterior Lumbar Interbody Fusion System (ALIF)
• 00814008020249: Instrument, Straight Inserter, Anterior Lumbar Interbody Fusion System (ALIF)
• 90814008024646: ALIF Encoded 29x39 20mm 12 Degree
• 90814008024639: ALIF Encoded 29x39 18mm 12 Degree
• 90814008024622: ALIF Encoded 29x39 16mm 12 degree
• 90814008024615: ALIF Encoded 29x39 14mm 12 Degree
• 90814008024608: ALIF Encoded 29x39 12mm 12 Degree
• 90814008024592: ALIF Encoded 29x39 10mm 12 Degree
• 90814008024585: ALIF Encoded 25x34 20mm 12 Degree
• 90814008024578: ALIF Encoded 25x34 18mm 12 Degree
• 90814008024561: ALIF Encoded 25x34 16mm 12 Degree
• 90814008024554: ALIF Encoded 25x34 14mm 12 Degree
• 90814008024547: ALIF Encoded 25x34 12mm 12 Degree
• 90814008024530: ALIF Encoded 25x34 10mm 12 Degree
• 90814008024523: ALIF Encoded 29x39 20mm 6 Degree