Orca™ Knotless Tendon Repair AB-6200

GUDID 00854629006925

Orca™ Knotless Tendon Repair

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: 00854629006925
• NIH Device Record Key: fc008557-304e-48e9-82cc-c7eaf80d3819
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orca™ Knotless Tendon Repair
• Version Model Number: AB-6200
• Catalog Number: AB-6200
• 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	00854629006925 [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: 2023-08-08
• Device Publish Date: 2023-07-31

Devices Manufactured by DUNAMIS MEDICAL, LLC

• 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
• 00850052601157 - Threaded Driver: 2024-06-18 Threaded Driver
• 00850052601232 - Micro Constrictor® Implantation Kit: 2024-06-18 Micro Constrictor® Implantation Kit
• 00850052601225 - Orca Xtreme ™ Kit Knotless Button: 2024-03-22 Orca Xtreme™ Kit Knotless Button
• 00850052601188 - Force DFX Suture-Xtreme™: 2024-02-08 Force DFX Suture-Xtreme™