BEUDAMED
    FDA Registration Active 🇺🇸 United States

    StrykerPR3324 (LS, VG) - 9 X 30mm Large Bore ACL Screw

    Reg #: 2648623 · FEI: 2648623 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STERIS ISOMEDIX PUERTO RICO, INC.
    Registration Number
    2648623
    FEI Number
    2648623
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    KM 1 7, STATE Road, 690, BARRIO SABANA HOYOS
    City
    Alts De Cerro Gordo 3&4
    State
    PR
    ZIP
    00692
    Country
    US

    Regulatory Submissions

    510(k) Number
    K952460

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    1527821
    Address
    5960 Heisley Rd, --
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC

    Proprietary Names

    StrykerPR3324 (LS, VG) - 9 X 30mm Large Bore ACL Screw StrykerPR3324 (LS, VG) - 10 X 30mm Large Bore ACL Screw StrykerPR3324 (LS, VG) - 8 X 30mm Large Bore ACL Screw StrykerPR3324 (LS, VG) - 9 X 30mm ACL Interference Screw StrykerPR3324 (LS, VG) - 10 X 20mm Large Bore ACL Screw StrykerPR3324 (LS, VG) - 10 X 25mm Large Bore ACL Screw StrykerPR3324 (LS, VG) - 7 X 30mm Large Bore ACL Screw

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)