BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SURGICAL PLANNING ASSOCIATES

    Reg #: 3008869747 · FEI: 3008869747 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    SURGICAL PLANNING ASSOCIATES
    Registration Number
    3008869747
    FEI Number
    3008869747
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    New England Baptist Hospital, 125 Parker Hill Ave Suite 545
    City
    Boston
    State
    MA
    ZIP
    02120
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200384

    Owner / Operator

    Firm Name
    Surgical Planning Associates
    Operator Number
    10035030
    Address
    New England Baptist Hospital, 125 Parker Hill Ave Suite 545
    City
    Boston
    State
    MA
    Postal Code
    02120
    Country
    US
    Correspondent
    Stephen B Murphy

    Products

    Device Name Product Code
    Patient Specific Manual Orthopedic Stereotaxic System OSF
    Orthopedic Augmented Reality SBF

    Proprietary Names

    HipInsight System HipXpert

    Establishment Types

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