ZAVATION ROD

GUDID 00197157015053

TIGER 2, CADDY, Ø 5.5MM

Zavation LLC

Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: 00197157015053
• NIH Device Record Key: c0952abb-6c36-4b61-a10d-0a8a0f5c0d8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZAVATION ROD
• Version Model Number: 14G00674
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197157015053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243908

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00197157015053]

Moist Heat or Steam Sterilization

[00197157015053]

Moist Heat or Steam Sterilization

[00197157015053]

Moist Heat or Steam Sterilization

[00197157015053]

Moist Heat or Steam Sterilization

[00197157015053]

Moist Heat or Steam Sterilization

[00197157015053]

Moist Heat or Steam Sterilization

[00197157015053]

Moist Heat or Steam Sterilization

[00197157015053]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-12
• Device Publish Date: 2025-06-04

Devices Manufactured by Zavation LLC

• 00197157016791 - ZAVATION ROD CONNECTOR: 2025-06-13 ROD CONNECTOR, PARALLEL TOP LOADING 14mm offset,5.5/6.0mm X 5.5/6.0mm
• 00197157016807 - ZAVATION ROD CONNECTOR: 2025-06-13 ROD CONNECTOR, PARALLEL TOP LOADING 10° offset,5.5/6.0mm X 5.5/6.0mm
• 00197157016814 - ZAVATION ROD CONNECTOR: 2025-06-13 ROD CONNECTOR, PARALLEL TOP LOADING 20°offset,5.5/6.0mm X 5.5/6.0mm
• 00197157016821 - ZAVATION ROD CONNECTOR: 2025-06-13 ROD CONNECTOR, PARALLEL TOP LOADING 30°offset,5.5/6.0mm X 5.5/6.0mm
• 00197157016838 - ZAVATION ROD CONNECTOR: 2025-06-13 ROD CONNECTOR, AXIAL CLOSED mm offset,3.5/4.0mm X 4.75/5.5mm
• 00197157016845 - ZAVATION ROD CONNECTOR: 2025-06-13 ROD CONNECTOR, AXIAL CLOSED mm offset,3.5/4.0mm X 5.5/6.0mm
• 00197157016852 - ZAVATION ROD CONNECTOR: 2025-06-13 ROD CONNECTOR, AXIAL CLOSED mm offset,4.75/5.5mm X 4.75/5.5mm
• 00197157016869 - ZAVATION ROD CONNECTOR: 2025-06-13 ROD CONNECTOR, AXIAL CLOSED mm offset,4.75/5.5mm X 5.5/6.0mm