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

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

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• 03701337601096 - QUANTUM: 2024-12-23 QUANTUM Pin Pusher
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• 00810021861067 - In2Bones: 2024-12-20 LOCKING DRILL GUIDE, 2.8 MM, NON-STERILE
• 00810021861449 - IBS-B: 2024-12-20 IBS-B MIS Compression Screw,Dia.3.3x52mm