ZAVATION CONNECTOR

GUDID 00197157021153

Open-Open/Large-Large 16mm Offset Connector

Zavation LLC

Bone-screw internal spinal fixation system connector

• Primary Device ID: 00197157021153
• NIH Device Record Key: e64c0629-cc33-4b17-9394-58c8198be904
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZAVATION CONNECTOR
• Version Model Number: 880-2233-16
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197157021153 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222614

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00197157021153]

Moist Heat or Steam Sterilization

[00197157021153]

Moist Heat or Steam Sterilization

[00197157021153]

Moist Heat or Steam Sterilization

[00197157021153]

Moist Heat or Steam Sterilization

[00197157021153]

Moist Heat or Steam Sterilization

[00197157021153]

Moist Heat or Steam Sterilization

[00197157021153]

Moist Heat or Steam Sterilization

[00197157021153]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-12
• Device Publish Date: 2025-06-04

On-Brand Devices [ZAVATION CONNECTOR]

• 00197157021221: Open-Open/Large-Xsmall 18mm Offset Connector
• 00197157021214: Open-Open/Large-Xsmall 16mm Offset Connector
• 00197157021207: Open-Open/Large-Xsmall 12mm Offset Connector
• 00197157021191: Open-Open/Small-Xsmall 18mm Offset Connector
• 00197157021184: Open-Open/Small-Xsmall 16mm Offset Connector
• 00197157021177: Open-Open/Small-Xsmall 12mm Offset Connector
• 00197157021160: Open-Open/Large-Large 18mm Offset Connector
• 00197157021153: Open-Open/Large-Large 16mm Offset Connector
• 00197157021139: Open-Open/Large-Small 18mm Offset Connector
• 00197157021122: Open-Open/Large-Small 16mm Offset Connector
• 00197157021115: Open-Open/Large-Small 12mm Offset Connector
• 00197157021108: Open-Open/Small-Small 18mm Offset Connector
• 00197157021092: Open-Open/Small-Small 16mm Offset Connector