BEUDAMED
    FDA Registration Active 🇺🇸 United States

    KNOTILUS+ 2.9x12.5MM PEEK, KNOTLESS ANCHOR

    Reg #: 2648666 · FEI: 2648666 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    STRYKER PUERTO RICO, LLC.
    Registration Number
    2648666
    FEI Number
    2648666
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    HWY. 3, KM. 131.2, LAS GUASIMAS IND. PARK
    City
    ARROYO
    State
    PR
    ZIP
    00714
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232683

    Owner / Operator

    Firm Name
    STRYKER CORP.
    Operator Number
    1811755
    Address
    4100 East Milham Ave.
    City
    Kalamazoo
    State
    MI
    Postal Code
    49001
    Country
    US

    Products

    Device Name Product Code
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Screw, Fixation, Bone HWC

    Proprietary Names

    KNOTILUS+ 2.9x12.5MM PEEK, KNOTLESS ANCHOR KNOTILUS+ 2.4x8.9MM PEEK, KNOTLESS ANCHOR, HIP KNOTILUS+ 2.9x15.5MM PEEK, KNOTLESS ANCHOR KNOTILUS+ 2.9x12.5MM PEEK, KNOTLESS ANCHOR, HIP KNOTILUS+ 2.4x11.3MM PEEK, KNOTLESS ANCHOR

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)