BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    Pangea Humerus Plating System

    Reg #: 8031020 · FEI: 3002807830 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    STRYKER GmbH
    Registration Number
    8031020
    FEI Number
    3002807830
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BOHNACKERWEG 1
    City
    SELZACH Solothurn
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K231262

    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
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC

    Proprietary Names

    Pangea Humerus Plating System Pangea Femur Plating System Pangea Fibula Plating System Pangea Tibia Plating System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device