Zavation HDL, FXD, BALL

GUDID 00197157021078

"HDL, FXD, BALL, FR 5/8-11, Ø1.80"

Zavation LLC

Orthopaedic osteotome handle

• Primary Device ID: 00197157021078
• NIH Device Record Key: 02934989-3f63-4f84-af42-ba77640d9bc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zavation HDL, FXD, BALL
• Version Model Number: Z-1063
• 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
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197157021078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222614

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[00197157021078]

Moist Heat or Steam Sterilization

[00197157021078]

Moist Heat or Steam Sterilization

[00197157021078]

Moist Heat or Steam Sterilization

[00197157021078]

Moist Heat or Steam Sterilization

[00197157021078]

Moist Heat or Steam Sterilization

[00197157021078]

Moist Heat or Steam Sterilization

[00197157021078]

Moist Heat or Steam Sterilization

[00197157021078]

Moist Heat or Steam Sterilization

[00197157021078]

Moist Heat or Steam Sterilization

[00197157021078]

Moist Heat or Steam Sterilization

[00197157021078]

Moist Heat or Steam Sterilization

[00197157021078]

Moist Heat or Steam Sterilization

[00197157021078]

Moist Heat or Steam Sterilization

[00197157021078]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-16
• Device Publish Date: 2024-09-06

Devices Manufactured by Zavation LLC

• 00197157050139 - Zavation CUSTOM SCREW HEIGHT ADJUSTER: 2025-02-06 CUSTOM 1/4 DRIVE SCREW HEIGHT ADJUSTER T-27
• 00197157049881 - Zavation INSERTER OUTTER SHAFT: 2025-01-21 INSERTER OUTTER SHAFT
• 00197157049898 - Zavation INSERTER INNER SHAFT: 2025-01-21 INSERTER INNER SHAFT
• 00197157049904 - Zavation STRAIGHT ROD: 2025-01-21 STRAIGHT ROD
• 00197157049911 - Zavation STRAIGHT ROD: 2025-01-21 STRAIGHT ROD
• 00197157049928 - Zavation CUSTOM DRILL GUIDE: 2025-01-21 CUSTOM DRILL GUIDE
• 00197157049935 - Zavation CUSTOM CERVICAL DRILL: 2025-01-21 CUSTOM CERVICAL DRILL
• 00197157049942 - Zavation CERVICAL SPLIT DRIVER: 2025-01-21 2.5mm CERVICAL SPLIT DRIVER