BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    PCD PREC. SYS LONG TUBE W/VertaPlex HV

    Reg #: 3020163307 · FEI: 3020163307 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Stryker Tijuana Operations
    Registration Number
    3020163307
    FEI Number
    3020163307
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Ave. Todos los santos No. 10802 Col. Leandro Valle
    City
    Tijuana Baja California
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K150582

    Owner / Operator

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

    US Agent

    Business Name
    Stryker
    Contact Name
    Denise Alicea
    Address
    Hwy. #3, Km. 131.2 Las Guasimas Ind. Park
    City
    Arroyo
    State
    PR
    ZIP
    00714
    Country
    US
    Email
    [email protected]
    Phone
    939 3072500 ext. 2686

    Products

    Device Name Product Code
    Cement, Bone, Vertebroplasty NDN
    Bone Cement LOD

    Proprietary Names

    PCD PREC. SYS LONG TUBE W/VertaPlex HV Autoplex with Vertaplex HV PCD Kit Long tube with VertaPlex HV PCD kit Short tube with Vertaplex HV AutoPlex M4 Kit A: Cement Mixer with VertaPlex ® HV AutoPlex M4 Kit B: Cement Mixer with VertaPlex ® HV Manifold compatible

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)