ZAVATION ROD

GUDID 00197157071806

5509 SERIES STRAIGHT ROD MIS, COBALT CHROME

Zavation LLC

Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: 00197157071806
• NIH Device Record Key: fb62dba5-e82b-4fae-826f-a07bcea9e693
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZAVATION ROD
• Version Model Number: R5509-500
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197157071806 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243908

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[00197157071806]

Moist Heat or Steam Sterilization

[00197157071806]

Moist Heat or Steam Sterilization

[00197157071806]

Moist Heat or Steam Sterilization

[00197157071806]

Moist Heat or Steam Sterilization

[00197157071806]

Moist Heat or Steam Sterilization

[00197157071806]

Moist Heat or Steam Sterilization

[00197157071806]

Moist Heat or Steam Sterilization

[00197157071806]

Moist Heat or Steam Sterilization

[00197157071806]

Moist Heat or Steam Sterilization

[00197157071806]

Moist Heat or Steam Sterilization

[00197157071806]

Moist Heat or Steam Sterilization

[00197157071806]

Moist Heat or Steam Sterilization

[00197157071806]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-23
• Device Publish Date: 2025-09-15

On-Brand Devices [ZAVATION ROD]

• 00197157015053: TIGER 2, CADDY, Ø 5.5MM
• 00197157071813: 5509 SERIES STRAIGHT ROD MIS, COBALT CHROME
• 00197157071806: 5509 SERIES STRAIGHT ROD MIS, COBALT CHROME
• 00197157071790: 5509 SERIES STRAIGHT ROD MIS, COBALT CHROME
• 00197157071783: 5509 SERIES STRAIGHT ROD MIS, COBALT CHROME
• 00197157071769: 5509 SERIES STRAIGHT ROD MIS, COBALT CHROME
• 00197157071752: 5509 SERIES STRAIGHT ROD MIS, COBALT CHROME
• 00197157071745: 5509 SERIES STRAIGHT ROD MIS, COBALT CHROME
• 00197157071738: 5509 SERIES STRAIGHT ROD MIS, COBALT CHROME "
• 00197157071721: 5509 SERIES STRAIGHT ROD MIS, COBALT CHROME
• 00197157071714: "5509 SERIES STRAIGHT ROD MIS, COBALT CHROME "
• 00197157071707: 5509 SERIES STRAIGHT ROD MIS, COBALT CHROME
• 00197157071691: 5509 SERIES STRAIGHT ROD MIS, COBALT CHROME
• 00197157071684: 5509 SERIES STRAIGHT ROD MIS, COBALT CHROME
• 00197157071677: 5509 SERIES STRAIGHT ROD MIS, COBALT CHROME
• 00197157071660: 5509 SERIES STRAIGHT ROD MIS, COBALT CHROME
• 00197157071653: 5509 SERIES STRAIGHT ROD MIS, COBALT CHROME
• 00197157071646: 5509 SERIES STRAIGHT ROD MIS, COBALT CHROME
• 00197157071639: 5509 SERIES STRAIGHT ROD MIS, COBALT CHROME
• 00197157071622: "5509 SERIES STRAIGHT ROD MIS, COBALT CHROME "
• 00197157071615: 5509 SERIES STRAIGHT ROD MIS, COBALT CHROME
• 00197157071608: 5509 SERIES STRAIGHT ROD MIS, COBALT CHROME
• 00197157071592: 5509 SERIES STRAIGHT ROD MIS, COBALT CHROME
• 00197157071585: 5509 SERIES STRAIGHT ROD MIS, COBALT CHROME