ZAVATON ROD INTRODUCER

GUDID 00197157015374

ROD INTRODUCER, 5.5mm

Zavation LLC

Internal spinal fixation procedure kit, reusable

• Primary Device ID: 00197157015374
• NIH Device Record Key: d6686f0c-8227-4879-8e48-4095222b4cbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZAVATON ROD INTRODUCER
• Version Model Number: 989-2021
• 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	00197157015374 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243908

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00197157015374]

Moist Heat or Steam Sterilization

[00197157015374]

Moist Heat or Steam Sterilization

[00197157015374]

Moist Heat or Steam Sterilization

[00197157015374]

Moist Heat or Steam Sterilization

[00197157015374]

Moist Heat or Steam Sterilization

[00197157015374]

Moist Heat or Steam Sterilization

[00197157015374]

Moist Heat or Steam Sterilization

[00197157015374]

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

Devices Manufactured by Zavation LLC

• 00197157071400 - ZAVATION ROD BENDER: 2025-09-23 INSITU BENDER - RIGHT 6.0 ROD
• 00197157071417 - ZAVATION ROD BENDER: 2025-09-23 INSITU BENDER - LEFT 6.0 ROD
• 00197157071455 - ZAVATION CADDY: 2025-09-23 TIGER 2 DEFORMITY IMPLANTS - HOOKS CADDY
• 00197157071462 - ZAVATION CADDY: 2025-09-23 TIGER 2 DEFORMITY IMPLANTS - FRACTURE SCREW CADDY (STANDARD OR CANNULATED)
• 00197157071479 - ZAVATION CADDY: 2025-09-23 TIGER 2 DEFORMITY IMPLANTS - FRACTURE SCREW- STANDARD LID
• 00197157071486 - ZAVATION CADDY: 2025-09-23 TIGER 2 DEFORMITY IMPLANTS - FRACTURE SCREW- CANNULATED LID
• 00197157071493 - ZAVATION CADDY: 2025-09-23 TIGER 2 DEFORMITY IMPLANTS - BIASED ANGLE SCREW CADDY (STANDARD OR REDUCTION)
• 00197157071509 - ZAVATION CADDY LID: 2025-09-23 TIGER 2 DEFORMITY IMPLANTS - BIASED ANGLE SCREW CADDY LID