BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Reline Cervical PA Screw Assembly Y.Y x ZZmm

    Reg #: 3006791286 · FEI: 3006791286 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    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
    K191553

    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
    Posterior Cervical Screw System NKG

    Proprietary Names

    Reline Cervical PA Screw Assembly Y.Y x ZZmm Reline Cervical FA Partially Threaded Screw Y.Y x ZZmm Adjustable Occipital Plate Reline Cervical Tall Lockscrew Connector, X Cross Connect Lockscrew, HEX Reline Cervical Polyaxial Screw Assembly Y.Y x ZZmm

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)