Orca™ Mini Knotless Button AB-6300

GUDID 20854629006912

Orca™ Mini Knotless Button

DUNAMIS MEDICAL, LLC

Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button

• Primary Device ID: 20854629006912
• NIH Device Record Key: d53e97a8-49d0-4b64-aa36-f2246b064e82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orca™ Mini Knotless Button
• Version Model Number: AB-6300
• Catalog Number: AB-6300
• 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	20854629006912 [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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• 00850052601188 - Force DFX Suture-Xtreme™: 2024-02-08 Force DFX Suture-Xtreme™
• 00850052601195 - Fixation Button-Oblong: 2024-02-08 Fixation Button-Oblong
• 20854629006912 - Orca™ Mini Knotless Button: 2024-02-08Orca™ Mini Knotless Button
• 20854629006912 - Orca™ Mini Knotless Button: 2024-02-08 Orca™ Mini Knotless Button
• 30854629006919 - Orca™ XL Knotless Tendon Repair: 2024-02-08 Orca™ XL Knotless Tendon Repair
• 40854629006916 - Orca™ Xtreme Knotless Button: 2024-02-08 Orca™ Xtreme Knotless Button
• 00850052601041 - Suture Passer - Single Loop: 2023-08-25 Suture Passer - Single Loop
• 00854629006321 - 5.5mm PunchTac™ Threaded Anchor PEEK: 2023-08-25 5.5mm PunchTac™ Threaded Anchor PEEK Preloaded with Two 2mm Fiber Connect (UHMWPE)