CoLink Vallux

GUDID 00810021866291

CoLink Vallux Plate

IN2BONES USA, LLC

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

• Primary Device ID: 00810021866291
• NIH Device Record Key: 0c9179e1-a662-4aa1-91f9-060923b50a97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoLink Vallux
• Version Model Number: P90 ST031
• Company DUNS: 079700711
• Company Name: IN2BONES USA, 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: 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: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810021866291 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212487

FDA Product Code

• HRS: Plate, Fixation, Bone

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: 2022-01-31
• Device Publish Date: 2022-01-21

Devices Manufactured by IN2BONES USA, LLC

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• 00810021863788 - In2Bones: 2025-01-03 Dense Bone Drill Kit, Sterile 2.3 & 2.8
• 00810021864242 - CoLink Afx: 2025-01-03 CoLink Afx Sterile Single Use Instrument Kit
• 00810021866062 - CoLag: 2025-01-03 CoLag Single Use Kit - Dia. 2.0/2.5
• 00810021866079 - CoLag: 2025-01-03 CoLag Single Use Kit - Dia. 3.0
• 00810021866086 - CoLag: 2025-01-03 CoLag Single Use Kit - Dia. 4.0
• 00810021866116 - CoLink: 2025-01-03 CoLink Afx Lag Drill Kit
• 00810021866932 - 5MS: 2025-01-03 5MS Reusable Instrument Set, NS