BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OrthoNovis Bone Plate and Screw System

    Reg #: 3015946784 · FEI: 3015946784 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    ORTHONOVIS, INC.
    Registration Number
    3015946784
    FEI Number
    3015946784
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1 Hargrove Grade, 2F
    City
    Palm Coast
    State
    FL
    ZIP
    32137
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130614

    Owner / Operator

    Firm Name
    OrthoNovis, Inc.
    Operator Number
    10061543
    Address
    1 Hargrove Grade, 2F
    City
    Palm Coast
    State
    FL
    Postal Code
    32137
    Country
    US
    Correspondent
    Ken West

    Products

    Device Name Product Code
    Washer, Bolt Nut HTN
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS

    Proprietary Names

    OrthoNovis Bone Plate and Screw System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device