VADER Pedicle System, S-Rod, Carbon/PEEK, multi-curved, HT1, Ø 6.0 x 300 mm 16-60-2MC30-1

GUDID 07640172551714

VADER Pedicle System, S-Rod, Carbon/PEEK, multi-curved, HT1, Ø 6.0 x 300 mm

icotec AG

Bone-screw internal spinal fixation system rod

• Primary Device ID: 07640172551714
• NIH Device Record Key: 9232a029-5422-46be-954e-030449db9a32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VADER Pedicle System, S-Rod, Carbon/PEEK, multi-curved, HT1, Ø 6.0 x 300 mm
• Version Model Number: 16-60-2MC30-1
• Catalog Number: 16-60-2MC30-1
• Company DUNS: 480789465
• Company Name: icotec AG
• 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: true
• 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: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640172551714 [Primary]

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-08-08
• Device Publish Date: 2023-01-12

Devices Manufactured by icotec AG

• 07640172552278 - VADER Pedicle System K-wire Dispenser, long For K-wire 1.6 x 472 mm, 1.1 x 472 m: 2025-06-03 VADER Pedicle System K-wire Dispenser, long For K-wire 1.6 x 472 mm, 1.1 x 472 mm
• 07640172552858 - VADER Pedicle System, Axial Connector, Ø 6.0 mm - Ø 6.0 mm: 2025-03-13 VADER Pedicle System, Axial Connector, Ø 6.0 mm - Ø 6.0 mm
• 07640172552865 - VADER Pedicle System, Parallel Connector, Closed, Ø 6.0 mm - Ø 6.0 mm: 2025-03-13 VADER Pedicle System, Parallel Connector, Closed, Ø 6.0 mm - Ø 6.0 mm
• 07640172552872 - icotec Systems, Torque-Limiting Adapter, 3.5 Nm: 2025-03-13 icotec Systems, Torque-Limiting Adapter, 3.5 Nm
• 07640172552889 - VADER Pedicle System, Screwdriver for Connectors, T15, 3.5 Nm: 2025-03-13 VADER Pedicle System, Screwdriver for Connectors, T15, 3.5 Nm
• 07640172553572 - VADER Pedicle System, Torque Wrench for Connectors, T15, 3.5 Nm: 2025-03-13 VADER Pedicle System, Torque Wrench for Connectors, T15, 3.5 Nm
• 07640172552896 - VADER Pedicle System, K-wire Dispenser, Extra Long, Ø 1.6 x 600 mm, Ø 1.1 x 600: 2024-12-02 VADER Pedicle System, K-wire Dispenser, Extra Long, Ø 1.6 x 600 mm, Ø 1.1 x 600
• 07640172552902 - VADER Pedicle System, K-wire, threaded, Nitinol, Ø 1.6 x 600 mm: 2024-12-02 VADER Pedicle System, K-wire, threaded, Nitinol, Ø 1.6 x 600 mm