CoLink Mfx C02 N1401

GUDID 00810021864785

TN PLATE TRIAL, STANDARD

IN2BONES USA, LLC

Surgical implant template, reusable

• Primary Device ID: 00810021864785
• NIH Device Record Key: 57333f87-b6a4-4501-a789-765694c27b58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoLink Mfx
• Version Model Number: C02 N1401
• Catalog Number: C02 N1401
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810021864785 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210060

FDA Product Code

• HWT: TEMPLATE

Sterilization

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

[00810021864785]

Moist Heat or Steam Sterilization

[00810021864785]

Moist Heat or Steam Sterilization

[00810021864785]

Moist Heat or Steam Sterilization

[00810021864785]

Moist Heat or Steam Sterilization

[00810021864785]

Moist Heat or Steam Sterilization

[00810021864785]

Moist Heat or Steam Sterilization

[00810021864785]

Moist Heat or Steam Sterilization

[00810021864785]

Moist Heat or Steam Sterilization

[00810021864785]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-12-31
• Device Publish Date: 2024-12-10

On-Brand Devices [CoLink Mfx]

• 00810021866512: LISFRANC TARGETING GUIDE, ASSEMBLY
• 00810021866499: LISFRANC TARGETING GUIDE, RATCHET TUBE, SUB-ASSEMBLY
• 00810021866482: LISFRANC TARGETING GUIDE, GUIDE CLAMP, SUB-ASSEMBLY
• 00810021866475: LISFRANC SCREW DEPTH GAUGE
• 00810021866468: LISFRANC K-WIRE GUIDE, Ø1.6 MM
• 00810021866451: LISFRANC TARGETING GUIDE, ROD
• 00810021866444: LISFRANC DRIVER, T15, CANNULATED, NON-STERILE
• 00810021866437: LISFRANC DRILL, Ø2.7 MM, CANNULATED, NON-STERILE
• 00810021866420: LisFranc Driver, T15, Cannulated, Sterile, Single-Use
• 00810021866413: Lisfranc Drill, Ø2.7 mm, Cannulated, Sterile, Single-Use
• 00810021864815: MEDIAL COLUMN NCM PLATE TRIAL, STANDARD
• 00810021864808: MEDIAL COLUMN TNC PLATE TRIAL, STANDARD
• 00810021864792: MEDIAL COLUMN BRIDGE PLATE TRIAL, STANDARD
• 00810021864785: TN PLATE TRIAL, STANDARD
• 00810021864778: NC PLATE TRIAL, STANDARD
• 00810021864761: 2ND/3RD LISFRANC PLATE TRIAL, LARGE
• 00810021864754: 2ND/3RD LISFRANC PLATE TRIAL, SMALL
• 00810021864747: 1ST/2ND LISFRANC PLATE TRIAL, SMALL, RIGHT
• 00810021864730: 1ST/2ND LISFRANC PLATE TRIAL, SMALL, LEFT
• 00810021864723: 1ST/2ND LISFRANC PLATE TRIAL, LARGE, RIGHT
• 00810021864709: 1ST TMT LISFRANC PLATE TRIAL
• 00810021864693: CoLink Mfx, TRANSVERSE WIRE GUIDE, Ø4.0 CoLag SCREW