BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Implant, MIS Bunion, Polyaxial Locking Screw - 3mm

    Reg #: 3006791286 · FEI: 3006791286 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ARCH MEDICAL SOLUTIONS - PHILADELPHIA, LLC DBA JADE PRECISION MEDICAL COMPONENTS
    Registration Number
    3006791286
    FEI Number
    3006791286
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3063 B Philmont Ave.
    City
    Huntingdon Valley
    State
    PA
    ZIP
    19006
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190658

    Owner / Operator

    Firm Name
    Arch Medical Solutions - Philadelphia, LLC DBA JADE PRECISIO
    Operator Number
    10023130
    Address
    3063 B Philmont Ave.
    City
    Huntingdon Valley
    State
    PA
    Postal Code
    19006
    Country
    US
    Correspondent
    Christopher Bates

    Products

    Device Name Product Code
    Plate, Fixation, Bone HRS

    Proprietary Names

    Implant, MIS Bunion, Polyaxial Locking Screw - 3mm Implant, MIS Bunion, 2.7mm Non-Locking Screw Implant, MIS Bunion Plate - Addtional Fixation Implant, MIS Bunion Plate

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)