BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Edge Upper Cervical System

    Reg #: 3009704301 · FEI: 3009704301 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    SPINAL SIMPLICITY, LLC
    Registration Number
    3009704301
    FEI Number
    3009704301
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6363 College Blvd, Suite 320
    City
    Overland Park
    State
    KS
    ZIP
    66211
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221307

    Owner / Operator

    Firm Name
    Spinal Simplicity, LLC
    Operator Number
    10041761
    Address
    6363 College Blvd, Suite 320
    City
    Overland Park
    State
    KS
    Postal Code
    66211
    Country
    US
    Correspondent
    Adam Rogers

    Products

    Device Name Product Code
    Appliance, Fixation, Spinal Interlaminal KWP
    Posterior Cervical Screw System NKG

    Proprietary Names

    Edge Upper Cervical System

    Establishment Types

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