Orca™ Knotless Button AB-6275

GUDID 10854629006915

Orca™ Knotless Button

DUNAMIS MEDICAL, LLC

Orthopaedic fixation suture button

• Primary Device ID: 10854629006915
• NIH Device Record Key: 9c7ab5e9-b8e4-4b32-992d-436fc7311a49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orca™ Knotless Button
• Version Model Number: AB-6275
• Catalog Number: AB-6275
• Company DUNS: 079471560
• Company Name: DUNAMIS MEDICAL, 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877-454-2186
• Email: info@dunamismedical.com
• Phone: 877-454-2186
• Email: info@dunamismedical.com
• Phone: 877-454-2186
• Email: info@dunamismedical.com
• Phone: 877-454-2186
• Email: info@dunamismedical.com
• Phone: 877-454-2186
• Email: info@dunamismedical.com
• Phone: 877-454-2186
• Email: info@dunamismedical.com
• Phone: 877-454-2186
• Email: info@dunamismedical.com
• Phone: 877-454-2186
• Email: info@dunamismedical.com
• Phone: 877-454-2186
• Email: info@dunamismedical.com
• Phone: 877-454-2186
• Email: info@dunamismedical.com
• Phone: 877-454-2186
• Email: info@dunamismedical.com
• Phone: 877-454-2186
• Email: info@dunamismedical.com
• Phone: 877-454-2186
• Email: info@dunamismedical.com
• Phone: 877-454-2186
• Email: info@dunamismedical.com
• Phone: 877-454-2186
• Email: info@dunamismedical.com
• Phone: 877-454-2186
• Email: info@dunamismedical.com
• Phone: 877-454-2186
• Email: info@dunamismedical.com
• Phone: 877-454-2186
• Email: info@dunamismedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10854629006915 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191319

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

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: 2023-08-09
• Device Publish Date: 2023-08-01

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• 00854629006789 - Constrictor® Mini Syndesmosis Repair Kit: 2024-09-27 Constrictor® Mini Syndesmosis Repair Kit
• 00850052601249 - Orca™ Implantation Kit: 2024-06-28 Orca™ Implantation Kit
• 00850052601072 - Hallux Guide: 2024-06-18 Hallux Guide