BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FacetFuse

    Reg #: 3005977257 · FEI: 3005977257 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SPINEFRONTIER, INC. DBA LESspine Innovations
    Registration Number
    3005977257
    FEI Number
    3005977257
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    200 Summit Drive, Suite 505
    City
    Burlington
    State
    MA
    ZIP
    01803
    Country
    US

    Regulatory Submissions

    510(k) Number
    K071420

    Owner / Operator

    Firm Name
    LESspine Innovations
    Operator Number
    9094359
    Address
    200 Summit Dr, Suite 505
    City
    Burlington
    State
    MA
    Postal Code
    01803
    Country
    US

    Products

    Device Name Product Code
    System, Facet Screw Spinal Device MRW

    Proprietary Names

    FacetFuse

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device