Zavation ZVplasty System Assembly

GUDID 00842166121546

ZVplasty System Assembly

Zavation LLC

Balloon kyphoplasty kit

• Primary Device ID: 00842166121546
• NIH Device Record Key: ad99adbc-3cee-46b5-9e0f-2847fb2583f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zavation ZVplasty System Assembly
• Version Model Number: VCF-1015-1-E
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842166121546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141419

FDA Product Code

• NDN: Cement, Bone, Vertebroplasty

Sterilization

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

[00842166121546]

Ethylene Oxide

[00842166121546]

Ethylene Oxide

[00842166121546]

Ethylene Oxide

[00842166121546]

Ethylene Oxide

[00842166121546]

Ethylene Oxide

[00842166121546]

Ethylene Oxide

[00842166121546]

Ethylene Oxide

[00842166121546]

Ethylene Oxide

[00842166121546]

Ethylene Oxide

[00842166121546]

Ethylene Oxide

[00842166121546]

Ethylene Oxide

[00842166121546]

Ethylene Oxide

[00842166121546]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-11
• Device Publish Date: 2024-11-01

Devices Manufactured by Zavation LLC

• 00197157060183 - ZAVATION F3D CORPECTOMY: 2025-07-22 F3D CORPECTOMY - 14.5MM X 12MM X 61MM, 0 DEG
• 00197157060190 - ZAVATION F3D CORPECTOMY: 2025-07-22 F3D CORPECTOMY - 14.5MM X 12MM X 62MM, 0 DEG
• 00197157060206 - ZAVATION F3D CORPECTOMY: 2025-07-22 F3D CORPECTOMY - 14.5MM X 12MM X 63MM, 0 DEG
• 00197157060213 - ZAVATION F3D CORPECTOMY: 2025-07-22 F3D CORPECTOMY - 14.5MM X 12MM X 64MM, 0 DEG
• 00197157060220 - ZAVATION F3D CORPECTOMY: 2025-07-22 F3D CORPECTOMY - 14.5MM X 12MM X 65MM, 0 DEG
• 00197157060237 - ZAVATION F3D CORPECTOMY: 2025-07-22 F3D CORPECTOMY - 14.5MM X 12MM X 66MM, 0 DEG
• 00197157060244 - ZAVATION F3D CORPECTOMY: 2025-07-22 F3D CORPECTOMY - 14.5MM X 12MM X 67MM, 0 DEG
• 00197157060251 - ZAVATION F3D CORPECTOMY: 2025-07-22 F3D CORPECTOMY - 14.5MM X 12MM X 68MM, 0 DEG