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

• 00197157015046 - ZAVATION GUIDE WIRE: 2025-06-12 GUIDE WIRE, 610mm SS, TROCAR TIP
• 00197157015053 - ZAVATION ROD: 2025-06-12 TIGER 2, CADDY, Ø 5.5MM
• 00197157015060 - ZAVATION PEDICLE PREP TRAY: 2025-06-12 TIGER 2, TRAY, PEDICLE PREP
• 00197157015077 - ZAVATION SCREW PLACEMENT TRAY: 2025-06-12 TIGER 2, TRAY, SCREW PLACEMENT
• 00197157015084 - ZAVATION TRAY: 2025-06-12 TIGER 2, TRAY, ROD REDUCTION AND LOCKING
• 00197157015091 - ZAVATION AUXILIARY REDUCERS: 2025-06-12 TIGER 2, TRAY, AUXILIARY REDUCERS
• 00197157015107 - ZAVATION TRAY: 2025-06-12 TIGER 2, TRAY, INNER LID
• 00197157015114 - ZAVATION IMPLANT TRAY: 2025-06-12 TIGER 2, TRAY, IMPLANTS