BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    ADLER ORTHO S.P.A.

    Reg #: 3008281151 · FEI: 3008281151 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    13
    Establishment Types
    2
    Classifications
    12

    Registration Details

    Registration Name
    ADLER ORTHO S.P.A.
    Registration Number
    3008281151
    FEI Number
    3008281151
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Via Dell'Innovazione 9
    City
    Cormano Milano
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K241059

    Owner / Operator

    Firm Name
    Adler Ortho S.p.A.
    Operator Number
    10086224
    Address
    Via Dell'Innovazione 9
    City
    Cormano
    State
    Milano
    Postal Code
    20032
    Country
    IT
    Correspondent
    Edgardo Cremascoli

    US Agent

    Business Name
    Pivot MedTech, LLC
    Contact Name
    Albert Nanni
    Address
    323 New Albany Rd
    City
    Moorestown
    State
    NJ
    ZIP
    08057
    Country
    US
    Email
    [email protected]
    Phone
    856 2961691

    Products

    Device Name Product Code
    Orthopedic Manual Surgical Instrument LXH
    Dispenser, Cement KIH
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Reamer HTO
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Upper Femoral JDD
    Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented OQH

    Proprietary Names

    HIP PROSTHESIS INSTRUMENTS Custom Made Device Instruments PRESSURIZER Pantheon Proximal Femur Reconstruction (PFR) System Custom-made, Knee, Constrained, Cemented, Metal/Polymer CUSTOM MADE HIP PROSTHESIS, UNCEMENTED, HA COATED CUSTOM MADE FEMORAL PROSTHESIS, POROUS & UNCEMENTED REAMER CUSTOM MADE HIP PROSTHESIS, UNCEMENTED CUSTOM MADE KNEE JOINT PROSTHESIS, UNCEMENTED CUSTOM MADE HIP PROSTHESIS, CEMENTED CUSTOM MADE UPPER FEMORAL PROSTHESIS CUSTOM MADE HIP PROSTHESIS, CEMENTED, ADDITIVE

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)