Zavation Custom Polyaxial Driver

GUDID 00197157019624

Custom Polyaxial Driver

Zavation LLC

Orthopaedic implant driver

• Primary Device ID: 00197157019624
• NIH Device Record Key: f1fc37c2-f4f7-40d1-ab56-0629b58f24d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zavation Custom Polyaxial Driver
• Version Model Number: ZAV-1354
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197157019624 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112484

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00197157019624]

Moist Heat or Steam Sterilization

[00197157019624]

Moist Heat or Steam Sterilization

[00197157019624]

Moist Heat or Steam Sterilization

[00197157019624]

Moist Heat or Steam Sterilization

[00197157019624]

Moist Heat or Steam Sterilization

[00197157019624]

Moist Heat or Steam Sterilization

[00197157019624]

Moist Heat or Steam Sterilization

[00197157019624]

Moist Heat or Steam Sterilization

[00197157019624]

Moist Heat or Steam Sterilization

[00197157019624]

Moist Heat or Steam Sterilization

[00197157019624]

Moist Heat or Steam Sterilization

[00197157019624]

Moist Heat or Steam Sterilization

[00197157019624]

Moist Heat or Steam Sterilization

[00197157019624]

Moist Heat or Steam Sterilization

[00197157019624]

Moist Heat or Steam Sterilization

[00197157019624]

Moist Heat or Steam Sterilization

[00197157019624]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-21
• Device Publish Date: 2024-11-13

Devices Manufactured by Zavation LLC

• 00197157064853 - ZAVATION F3D CORPECTOMY: 2025-09-04 F3D CORPECTOMY - 18MM X 14MM X 40MM, 12 DEG
• 00197157064860 - ZAVATION F3D CORPECTOMY: 2025-09-04 F3D CORPECTOMY - 18MM X 14MM X 41MM, 12 DEG
• 00197157064877 - ZAVATION F3D CORPECTOMY: 2025-09-04 F3D CORPECTOMY - 18MM X 14MM X 42MM, 12 DEG
• 00197157064884 - ZAVATION F3D CORPECTOMY: 2025-09-04 F3D CORPECTOMY - 18MM X 14MM X 43MM, 12 DEG
• 00197157064891 - ZAVATION F3D CORPECTOMY: 2025-09-04 F3D CORPECTOMY - 18MM X 14MM X 44MM, 12 DEG
• 00197157064907 - ZAVATION F3D CORPECTOMY: 2025-09-04 F3D CORPECTOMY - 18MM X 14MM X 45MM, 12 DEG
• 00197157064914 - ZAVATION F3D CORPECTOMY: 2025-09-04 F3D CORPECTOMY - 18MM X 14MM X 46MM, 12 DEG
• 00197157064921 - ZAVATION F3D CORPECTOMY: 2025-09-04 F3D CORPECTOMY - 18MM X 14MM X 47MM, 12 DEG