ZAVATION HEAD ADJUSTER

GUDID 00197157014582

TIGER 2 HEAD ADJUSTER MIS

Zavation LLC

Orthopaedic inorganic implant inserter/extractor, reusable

• Primary Device ID: 00197157014582
• NIH Device Record Key: 715560ac-deaf-4c3b-9cd9-fcba77920d4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZAVATION HEAD ADJUSTER
• Version Model Number: 989-2003
• 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	00197157014582 [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

[00197157014582]

Moist Heat or Steam Sterilization

[00197157014582]

Moist Heat or Steam Sterilization

[00197157014582]

Moist Heat or Steam Sterilization

[00197157014582]

Moist Heat or Steam Sterilization

[00197157014582]

Moist Heat or Steam Sterilization

[00197157014582]

Moist Heat or Steam Sterilization

[00197157014582]

Moist Heat or Steam Sterilization

[00197157014582]

Moist Heat or Steam Sterilization

[00197157014582]

Moist Heat or Steam Sterilization

[00197157014582]

Moist Heat or Steam Sterilization

[00197157014582]

Moist Heat or Steam Sterilization

[00197157014582]

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 HEAD ADJUSTER]

• 00197157014582: TIGER 2 HEAD ADJUSTER MIS
• 00197157014575: TIGER 2 HEAD ADJUSTER