CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 5.0 × 35 mm 16-4020-35035

GUDID 07640172553329

CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 5.0 × 35 mm

icotec AG

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 07640172553329
• NIH Device Record Key: d2cd9bfc-8cd3-4d9e-846d-7c97344744bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 5.0 × 35 mm
• Version Model Number: 16-4020-35035
• Catalog Number: 16-4020-35035
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640172553329 [Primary]

FDA Product Code

• NKG: Posterior Cervical Screw System

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-02
• Device Publish Date: 2025-11-24

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• 07640172552568 - CMORE® System, Drill Guide Sleeve: 2025-12-02 CMORE® System, Drill Guide Sleeve
• 07640172552575 - CMORE® System, Drill Guide Stop: 2025-12-02 CMORE® System, Drill Guide Stop
• 07640172552582 - CMORE® System, Drill Bit, Ø 2.3 mm: 2025-12-02 CMORE® System, Drill Bit, Ø 2.3 mm
• 07640172552599 - CMORE® System, Feeler: 2025-12-02 CMORE® System, Feeler
• 07640172552605 - CMORE® System, In-line Handle, AO Coupling: 2025-12-02 CMORE® System, In-line Handle, AO Coupling
• 07640172552612 - CMORE® System, Palm Handle, AO Coupling: 2025-12-02 CMORE® System, Palm Handle, AO Coupling