Zavation Pedicle Screw Head Assembly Tool

GUDID 00197157019655

Pedicle Screw Head Assembly Tool/10.5, & 11.5

Zavation LLC

Internal spinal fixation procedure kit, reusable

• Primary Device ID: 00197157019655
• NIH Device Record Key: 6e1f4466-5d91-470d-a90d-79972298cf8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zavation Pedicle Screw Head Assembly Tool
• Version Model Number: ZAV-1353-3
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197157019655 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112484

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00197157019655]

Moist Heat or Steam Sterilization

[00197157019655]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-21
• Device Publish Date: 2024-11-13

On-Brand Devices [Zavation Pedicle Screw Head Assembly Tool]

• 00197157019655: Pedicle Screw Head Assembly Tool/10.5, & 11.5
• 00197157019648: Pedicle Screw Head Assembly Tool/4.5,8.5, & 9.5
• 00197157019631: Pedicle Screw Head Assembly Tool/5.5,6.5, & 7.5