CoLink® Mfx

GUDID 00810021864563

CoLink® Mfx, 1st TMT Lisfranc Plate, Small, Left

IN2BONES USA, LLC

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

• Primary Device ID: 00810021864563
• NIH Device Record Key: 84dd50ba-7cd3-4b9c-8fdf-7da254ab40d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoLink® Mfx
• Version Model Number: C20 ST211
• 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: true
• 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	00810021864563 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210060

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: 2021-08-23
• Device Publish Date: 2021-08-13

On-Brand Devices [CoLink® Mfx]

• 00810021864686: CoLink® Mfx, TN Plate, Standard
• 00810021864679: CoLink® Mfx, Medial Column NCM Plate, Standard
• 00810021864662: CoLink® Mfx, Medial Column TNC Plate, Standard
• 00810021864655: CoLink® Mfx, Medial Column Bridge Plate, Standard
• 00810021864648: CoLink® Mfx, NC Plate, Standard
• 00810021864631: CoLink® Mfx, 2nd/3rd Lisfranc Plate, Large
• 00810021864624: CoLink® Mfx, 2nd/3rd Lisfranc Plate, Small
• 00810021864617: CoLink® Mfx, 1st/2nd Lisfranc Plate, Small, Right
• 00810021864600: CoLink® Mfx, 1st/2nd Lisfranc Plate, Small, Left
• 00810021864594: CoLink® Mfx, 1st/2nd Lisfranc Plate, Large, Right
• 00810021864587: CoLink® Mfx, 1st/2nd Lisfranc Plate, Large, Left
• 00810021864570: CoLink® Mfx, 1st TMT Lisfranc Plate, Small, Right
• 00810021864563: CoLink® Mfx, 1st TMT Lisfranc Plate, Small, Left