BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SMR Stemless Anatomic

    Reg #: 3020967480 · FEI: 3020967480 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ProMade PoC Center for Complex Orthopedic Solutions at HSS
    Registration Number
    3020967480
    FEI Number
    3020967480
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    510 East 73rd St. (1st floor)
    City
    Manhattan
    State
    NY
    ZIP
    10021
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221758

    Owner / Operator

    Firm Name
    Limacorporate S.p.A.
    Operator Number
    10032506
    Address
    Via Nazionale 52
    City
    Villanova di San Daniele
    State
    Udine
    Postal Code
    33038
    Country
    IT
    Correspondent
    Roberto Gabetta

    Products

    Device Name Product Code
    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC

    Proprietary Names

    SMR Stemless Anatomic

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)