BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Dunamis Fixation Button System

    Reg #: 3011061237 · FEI: 3011061237 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    26
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Dunamis Medical LLC
    Registration Number
    3011061237
    FEI Number
    3011061237
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    104 Camellia Ave, Suite B
    City
    Greenville
    State
    AL
    ZIP
    36037
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191319

    Owner / Operator

    Firm Name
    Dunamis Medical LLC
    Operator Number
    10047203
    Address
    104 Camellia Ave, Suite B
    City
    Greenville
    State
    AL
    Postal Code
    36037
    Country
    US
    Correspondent
    Prithviraj Chavan

    Products

    Device Name Product Code
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Washer, Bolt Nut HTN

    Proprietary Names

    Dunamis Fixation Button System Constrictor ® Syndesmosis Repair Kit Constrictor® Mini Syndex Constrictor® Implant Kit Constrictor® Mini Button Extender ORCA™ Knotless Tendon Repair Constrictor ® Rope Constrictor® Button Extender Fixation Button-Oblong Constrictor® Mini Snare Constrictor ® 2 Repair Kit Orca™ Xtreme Tendon Repair Kit Constrictor® Link Micro Constrictor ® Orca™ Knotless Button Micro ORCA™ Micro Constrictor ® X Orca™ XL Knotless Tendon Repair Olecranon Transporter™ Repair Kit Constrictor® Link (AC) Constrictor ® Mini 2 Repair Kit ENOFIX™ with Constrictor® Technology Syndesmotic Fixation Kit Micro Constrictor® Link Orca™ Xtreme Tendon Repair ORCA™ Mini Knotless Tendon Repair Constrictor ® Mini Repair Kit

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device