BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RMM Modular Tulip Assembly

    Reg #: 3006791286 · FEI: 3006791286 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    13
    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
    K182974

    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

    RMM Modular Tulip Assembly Reline Screw XX.X x YYmm 2S Ilian Closed Reline Screw XX.X x YYmm 2F Polyaxial Reline Screw X.X x YYmm Poly 2C MAS Reduction Reline 5.5mm Open Tulip Lock Screw Reline Open Reduction Tulip, MOD Reline Screw XX.X x YYmm 2S Reduction Reline Screw XX.X x YYmm 2S Polyaxial Reline Modular Tulip Assembly Reline Screw XX.X x YYmm 2C Polyaxial RMM XX.X x YYmm 4S Polyaxial Screw .285 Solid Cancellous Shank X.X x YYmm Reline MOD MAS Reduction Screw Tulip

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)