BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FlareHawk Interbody Fusion System

    Reg #: 3012797630 · FEI: 3012797630 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    INTEGRITY IMPLANTS INC.
    Registration Number
    3012797630
    FEI Number
    3012797630
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    354 Hiatt Drive
    City
    Palm Bch Gdns
    State
    FL
    ZIP
    33418
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182114

    Owner / Operator

    Firm Name
    Integrity Implants Inc.
    Operator Number
    10052256
    Address
    354 Hiatt Dr
    City
    Palm Beach Gardens
    State
    FL
    Postal Code
    33418
    Country
    US
    Correspondent
    Chris McKee

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX

    Proprietary Names

    FlareHawk Interbody Fusion System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Manufacture Medical Device