ZAVATION VARISYNC ALIF SIZER

GUDID 00197157072841

VARISYNC ALIF SIZER

Zavation LLC

Surgical implant/trial-implant/sizer holder, reusable

• Primary Device ID: 00197157072841
• NIH Device Record Key: 46c9fc46-3e79-4983-8e07-0f9d3c92a59a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZAVATION VARISYNC ALIF SIZER
• Version Model Number: 869-1052-3035-21-R
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197157072841 [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: false

[00197157072841]

Moist Heat or Steam Sterilization

[00197157072841]

Moist Heat or Steam Sterilization

[00197157072841]

Moist Heat or Steam Sterilization

[00197157072841]

Moist Heat or Steam Sterilization

[00197157072841]

Moist Heat or Steam Sterilization

[00197157072841]

Moist Heat or Steam Sterilization

[00197157072841]

Moist Heat or Steam Sterilization

[00197157072841]

Moist Heat or Steam Sterilization

[00197157072841]

Moist Heat or Steam Sterilization

[00197157072841]

Moist Heat or Steam Sterilization

[00197157072841]

Moist Heat or Steam Sterilization

[00197157072841]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-11
• Device Publish Date: 2025-09-03

On-Brand Devices [ZAVATION VARISYNC ALIF SIZER]

• 00197157072896: VARISYNC ALIF SIZER
• 00197157072889: VARISYNC ALIF SIZER
• 00197157072872: VARISYNC ALIF SIZER
• 00197157072865: VARISYNC ALIF SIZER
• 00197157072858: VARISYNC ALIF SIZER
• 00197157072841: VARISYNC ALIF SIZER
• 00197157072834: VARISYNC ALIF SIZER
• 00197157072827: VARISYNC ALIF SIZER
• 00197157072810: VARISYNC ALIF SIZER
• 00197157072803: VARISYNC ALIF SIZER
• 00197157072797: VARISYNC ALIF SIZER
• 00197157072780: VARISYNC ALIF SIZER
• 00197157072773: VARISYNC ALIF SIZER
• 00197157072766: VARISYNC ALIF SIZER
• 00197157072759: VARISYNC ALIF SIZER
• 00197157072742: VARISYNC ALIF SIZER
• 00197157072735: VARISYNC ALIF SIZER
• 00197157072728: VARISYNC ALIF SIZER
• 00197157072711: VARISYNC ALIF SIZER
• 00197157072704: VARISYNC ALIF SIZER
• 00197157072698: VARISYNC ALIF SIZER
• 00197157072681: VARISYNC ALIF SIZER
• 00197157072674: VARISYNC ALIF SIZER
• 00197157072667: VARISYNC ALIF SIZER
• 00197157072650: VARISYNC ALIF SIZER
• 00197157072643: VARISYNC ALIF SIZER
• 00197157072636: VARISYNC ALIF SIZER
• 00197157072629: VARISYNC ALIF SIZER
• 00197157072612: VARISYNC ALIF SIZER
• 00197157072605: VARISYNC ALIF SIZER
• 00197157072599: VARISYNC ALIF SIZER
• 00197157072582: VARISYNC ALIF SIZER
• 00197157072575: VARISYNC ALIF SIZER
• 00197157072568: VARISYNC ALIF SIZER
• 00197157072551: VARISYNC ALIF SIZER
• 00197157072544: VARISYNC ALIF SIZER
• 00197157072537: VARISYNC ALIF SIZER
• 00197157072520: VARISYNC ALIF SIZER
• 00197157072513: VARISYNC ALIF SIZER
• 00197157072506: VARISYNC ALIF SIZER
• 00197157072490: VARISYNC ALIF SIZER
• 00197157072483: VARISYNC ALIF SIZER
• 00197157072476: VARISYNC ALIF SIZER
• 00197157072469: VARISYNC ALIF SIZER
• 00197157072452: VARISYNC ALIF SIZER
• 00197157072445: VARISYNC ALIF SIZER
• 00197157072438: VARISYNC ALIF SIZER
• 00197157072421: VARISYNC ALIF SIZER
• 00197157072414: VARISYNC ALIF SIZER
• 00197157072407: VARISYNC ALIF SIZER