ZAVATION VARISYNC ALIF TI3Z CAGE

GUDID 00197157022501

VARISYNC® ALIF, TI3Z CAGE - 30X14MMX15°

Zavation LLC

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00197157022501
• NIH Device Record Key: ae536797-712d-48e3-b2b6-cb3fa18cf185
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZAVATION VARISYNC ALIF TI3Z CAGE
• Version Model Number: 861-3Z-1530-14
• Company DUNS: 069472800
• Company Name: Zavation LLC
• 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: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197157022501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230731

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00197157022501]

Radiation Sterilization

[00197157022501]

Radiation Sterilization

[00197157022501]

Radiation Sterilization

[00197157022501]

Radiation Sterilization

[00197157022501]

Radiation Sterilization

[00197157022501]

Radiation Sterilization

[00197157022501]

Radiation Sterilization

[00197157022501]

Radiation Sterilization

[00197157022501]

Radiation Sterilization

[00197157022501]

Radiation Sterilization

[00197157022501]

Radiation Sterilization

[00197157022501]

Radiation Sterilization

[00197157022501]

Radiation Sterilization

[00197157022501]

Radiation Sterilization

[00197157022501]

Radiation Sterilization

[00197157022501]

Radiation Sterilization

[00197157022501]

Radiation Sterilization

[00197157022501]

Radiation Sterilization

[00197157022501]

Radiation Sterilization

[00197157022501]

Radiation Sterilization

[00197157022501]

Radiation Sterilization

[00197157022501]

Radiation Sterilization

[00197157022501]

Radiation Sterilization

[00197157022501]

Radiation Sterilization

[00197157022501]

Radiation Sterilization

[00197157022501]

Radiation Sterilization

[00197157022501]

Radiation Sterilization

[00197157022501]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-02
• Device Publish Date: 2025-06-30

On-Brand Devices [ZAVATION VARISYNC ALIF TI3Z CAGE]

• 00197157022501: VARISYNC® ALIF, TI3Z CAGE - 30X14MMX15°
• 00197157022495: VARISYNC® ALIF, TI3Z CAGE - 30X13MMX15°
• 00197157022488: VARISYNC® ALIF, TI3Z CAGE - 30X12MMX15°
• 00197157022471: VARISYNC® ALIF, TI3Z CAGE - 30X11MMX15°
• 00197157022464: VARISYNC® ALIF, TI3Z CAGE - 40X21MMX8°
• 00197157022457: VARISYNC® ALIF, TI3Z CAGE - 40X19MMX8°
• 00197157022440: VARISYNC® ALIF, TI3Z CAGE - 40X17MMX8°
• 00197157022433: VARISYNC® ALIF, TI3Z CAGE - 40X15MMX8°
• 00197157022426: VARISYNC® ALIF, TI3Z CAGE - 40X14MMX8°
• 00197157022419: VARISYNC® ALIF, TI3Z CAGE - 40X13MMX8°
• 00197157022402: VARISYNC® ALIF, TI3Z CAGE - 40X12MMX8°
• 00197157022396: VARISYNC® ALIF, TI3Z CAGE - 40X11MMX8°