Zavation Inserter Graft Pusher

GUDID 00197157019600

Custom Inserter Graft Pusher

Zavation LLC

Orthopaedic graft inserter, reusable

• Primary Device ID: 00197157019600
• NIH Device Record Key: 759c7354-e793-4727-9855-e0c0e950852b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zavation Inserter Graft Pusher
• Version Model Number: ZAV-1356
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197157019600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191339

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[00197157019600]

Moist Heat or Steam Sterilization

[00197157019600]

Moist Heat or Steam Sterilization

[00197157019600]

Moist Heat or Steam Sterilization

[00197157019600]

Moist Heat or Steam Sterilization

[00197157019600]

Moist Heat or Steam Sterilization

[00197157019600]

Moist Heat or Steam Sterilization

[00197157019600]

Moist Heat or Steam Sterilization

[00197157019600]

Moist Heat or Steam Sterilization

[00197157019600]

Moist Heat or Steam Sterilization

[00197157019600]

Moist Heat or Steam Sterilization

[00197157019600]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-12
• Device Publish Date: 2024-09-04

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