Hercules® Syndesmosis Implant System

GUDID 00810021861470

Hercules™ Syndesmosis Implant System Kit

IN2BONES USA, LLC

Orthopaedic fixation suture button

• Primary Device ID: 00810021861470
• NIH Device Record Key: 9b222891-857b-416d-8584-c28ed604101f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hercules® Syndesmosis Implant System
• Version Model Number: A80 ST100
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810021861470 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220260

FDA Product Code

• HTN: Washer, Bolt Nut

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: 2022-04-26
• Device Publish Date: 2022-04-18

Devices Manufactured by IN2BONES USA, LLC

• 00810021860121 - Hercules: 2025-01-06 Hercules Knotless Anchor Instrument Kit, Size 2.5mm
• 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