BEUDAMED
    FDA Registration Active 🇺🇸 United States

    aprevo® Inserter

    Reg #: 3017936978 · FEI: 3017936978 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    CARLSMED, INC.
    Registration Number
    3017936978
    FEI Number
    3017936978
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1800 Aston Avenue, Suite 100
    City
    Carlsbad
    State
    CA
    ZIP
    92008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222009

    Owner / Operator

    Firm Name
    Carlsmed, Inc.
    Operator Number
    10080208
    Address
    1800 Aston Avenue, Suite 100
    City
    Carlsbad
    State
    CA
    Postal Code
    92008
    Country
    US
    Correspondent
    Mike Cordonnier

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD

    Proprietary Names

    aprevo® Inserter aprevo® anterior lumbar interbody fusion device with interfixation

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198