BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RSS XX.X x YYmm 2S Polyaxial Screw

    Reg #: 3006791286 · FEI: 3006791286 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    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
    K190636

    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
    Thoracolumbosacral Pedicle Screw System NKB

    Proprietary Names

    RSS XX.X x YYmm 2S Polyaxial Screw RSS TGR Connector Assy XXmm Straight RSS XX.X x YYmm 2S Uniplanar Screw RSS XX.X x YYmm 2S Uni-Reduction Screw RSS XX.X x YYmm 2S Reduction Screw RSS 2H In-Line CON, 4.5 - 6mm ROD RSS 2H Parallel CON, 4.5 - 6mm ROD RSS 4H In-Line CON, 4.5 - 6mm ROD RSS 4H Parallel CON, 4.5 - 6mm ROD RSS Uni-Reduction Tulip RSS X.X x YYmm 2S Monoaxial

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)