BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AR-8920CDS Tightrope Syndemosis Repair Cannulated

    Reg #: 1226146 · FEI: 3002680121 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    R.K. Manufacturing
    Registration Number
    1226146
    FEI Number
    3002680121
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    34 Executive Drive
    City
    Danbury
    State
    CT
    ZIP
    06810
    Country
    US

    Regulatory Submissions

    510(k) Number
    K043248

    Owner / Operator

    Firm Name
    R.K. MFG. CORP. OF CONNECTICUT
    Operator Number
    10024924
    Address
    R.K. Manufacturing, 34 Executive Drive
    City
    Danbury
    State
    CT
    Postal Code
    06810
    Country
    US

    Products

    Device Name Product Code
    Washer, Bolt Nut HTN

    Proprietary Names

    AR-8920CDS Tightrope Syndemosis Repair Cannulated AR-8921CDS Tightrope Syndemosis Repair Cannulated AR-8926SS Knotless T-Rope Syn-Demosis Repr Kit, SS AR-8926T Knotless T-Rope Syn-Demosis Repr Ti

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)