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

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

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