BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CHECKPOINT SURGICAL INC.

    Reg #: 3012222873 · FEI: 3012222873 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    CHECKPOINT SURGICAL INC.
    Registration Number
    3012222873
    FEI Number
    3012222873
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6050 Oak Tree Blvd Ste 360
    City
    Independence
    State
    OH
    ZIP
    44131
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212355

    Owner / Operator

    Firm Name
    Checkpoint Surgical Inc.
    Operator Number
    10053637
    Address
    6050 Oak Tree Blvd., Suite 360
    City
    Independence
    State
    OH
    Postal Code
    44131
    Country
    US
    Correspondent
    Matt Hildebrand

    Products

    Device Name Product Code
    Stimulator, Nerve ETN
    Instrument, Surgical, Non-Powered HAO
    Cuff, Nerve JXI

    Proprietary Names

    Checkpoint Guardian Intraoperative Lead, Medium Checkpoint Guardian Intraoperative Lead, Large Checkpoint Guardian Intraoperative Lead, Small Checkpoint Stimulator Checkpoint Edge Nerve Cutting Kit Checkpoint Checkpoint Guardian Checkpoint Gemini Checkpoint Probe Extension NeuroShield ProVeil Checkpoint Head & Neck

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility