ZAVATION TIGHTENER

GUDID 00197157014841

TIGER 2 FINAL TIGHTENER, T27

Zavation LLC

Internal spinal fixation procedure kit, reusable

• Primary Device ID: 00197157014841
• NIH Device Record Key: 31f288af-a933-4620-b98d-0cf2d0990073
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZAVATION TIGHTENER
• Version Model Number: 989-1056
• 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
• Phone: 6019191119
• Email: info@zavation.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197157014841 [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

[00197157014841]

Moist Heat or Steam Sterilization

[00197157014841]

Moist Heat or Steam Sterilization

[00197157014841]

Moist Heat or Steam Sterilization

[00197157014841]

Moist Heat or Steam Sterilization

[00197157014841]

Moist Heat or Steam Sterilization

[00197157014841]

Moist Heat or Steam Sterilization

[00197157014841]

Moist Heat or Steam Sterilization

[00197157014841]

Moist Heat or Steam Sterilization

[00197157014841]

Moist Heat or Steam Sterilization

[00197157014841]

Moist Heat or Steam Sterilization

[00197157014841]

Moist Heat or Steam Sterilization

[00197157014841]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-11
• Device Publish Date: 2025-06-03

On-Brand Devices [ZAVATION TIGHTENER]

• 00197157014841: TIGER 2 FINAL TIGHTENER, T27
• 00197157014834: TIGER 2 FINAL TIGHTENER, T15