Orca™ Xtreme Knotless Button AB-6900

GUDID 40854629006916

Orca™ Xtreme Knotless Button

DUNAMIS MEDICAL, LLC

Orthopaedic fixation suture button

• Primary Device ID: 40854629006916
• NIH Device Record Key: 7fbcf8f1-198c-4739-8094-27f2e89f545b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orca™ Xtreme Knotless Button
• Version Model Number: AB-6900
• Catalog Number: AB-6900
• 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	40854629006916 [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: 2024-02-08
• Device Publish Date: 2024-01-31

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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
• 00850052601089 - CMC Spacer: 2024-06-18 CMC Spacer
• 00850052601096 - CMC Guide: 2024-06-18 CMC Guide