Zavation Custom Inserter

GUDID 00197157019327

Custom Inserter

Zavation LLC

Orthopaedic inorganic implant inserter/extractor, reusable

• Primary Device ID: 00197157019327
• NIH Device Record Key: 09e0380d-e29a-49d0-968b-0498ce02c949
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zavation Custom Inserter
• Version Model Number: ZAV-1348
• 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	00197157019327 [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

[00197157019327]

Moist Heat or Steam Sterilization

[00197157019327]

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

Devices Manufactured by Zavation LLC

• 00197157019327 - Zavation Custom Inserter: 2024-11-21Custom Inserter
• 00197157019327 - Zavation Custom Inserter: 2024-11-21 Custom Inserter
• 00197157019334 - Zavation CURVED CURETTE: 2024-11-21 CURVED CURETTE, 11ga, SHALLOW
• 00197157019624 - Zavation Custom Polyaxial Driver: 2024-11-21 Custom Polyaxial Driver
• 00197157019631 - Zavation Pedicle Screw Head Assembly Tool: 2024-11-21 Pedicle Screw Head Assembly Tool/5.5,6.5, & 7.5
• 00197157019648 - Zavation Pedicle Screw Head Assembly Tool: 2024-11-21 Pedicle Screw Head Assembly Tool/4.5,8.5, & 9.5
• 00197157019655 - Zavation Pedicle Screw Head Assembly Tool: 2024-11-21 Pedicle Screw Head Assembly Tool/10.5, & 11.5
• 00842166130081 - Zavation Solid Standard Modular Screw: 2024-11-20 Solid Standard Modular Screw 10.5x110
• 00842166194809 - Zavation Modular Screw: 2024-11-20 Modular Screw 8.5x110