BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED)

    Reg #: 3008812560 · FEI: 3008812560 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Synthes (USA) Products LLC
    Registration Number
    3008812560
    FEI Number
    3008812560
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1301 Goshen Pkwy
    City
    West Chester
    State
    PA
    ZIP
    19380
    Country
    US

    Regulatory Submissions

    510(k) Number
    K031654

    Owner / Operator

    Firm Name
    SYNTHES (USA) Products LLC / Medical Device Business Service
    Operator Number
    2520274
    Address
    1301 Goshen Parkway, --
    City
    West Chester
    State
    PA
    Postal Code
    19380
    Country
    US

    Products

    Device Name Product Code
    Fastener, Plate, Cranioplasty HBW
    Cover, Burr Hole GXR

    Proprietary Names

    SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198