Zavation Torque Shaft

GUDID 00197157010287

Connector System Torque Shaft

Zavation LLC

Internal spinal fixation procedure kit, reusable

• Primary Device ID: 00197157010287
• NIH Device Record Key: 9f27e33a-8303-4097-bc41-ba8e7ef728b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zavation Torque Shaft
• Version Model Number: 880-1014
• 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
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197157010287 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222614

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[00197157010287]

Moist Heat or Steam Sterilization

[00197157010287]

Moist Heat or Steam Sterilization

[00197157010287]

Moist Heat or Steam Sterilization

[00197157010287]

Moist Heat or Steam Sterilization

[00197157010287]

Moist Heat or Steam Sterilization

[00197157010287]

Moist Heat or Steam Sterilization

[00197157010287]

Moist Heat or Steam Sterilization

[00197157010287]

Moist Heat or Steam Sterilization

[00197157010287]

Moist Heat or Steam Sterilization

[00197157010287]

Moist Heat or Steam Sterilization

[00197157010287]

Moist Heat or Steam Sterilization

[00197157010287]

Moist Heat or Steam Sterilization

[00197157010287]

Moist Heat or Steam Sterilization

[00197157010287]

Moist Heat or Steam Sterilization

[00197157010287]

Moist Heat or Steam Sterilization

[00197157010287]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-11-04
• Device Publish Date: 2024-09-05

Devices Manufactured by Zavation LLC

• 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
• 00197157049843 - Zavation PEDICLE AWL: 2025-01-14 PEDICLE AWL