BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SUBCHONDRAL SOLUTIONS

    Reg #: 3016660811 · FEI: 3016660811 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    3

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    Registration Details

    Registration Name
    SUBCHONDRAL SOLUTIONS
    Registration Number
    3016660811
    FEI Number
    3016660811
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1725 Monrovia Ave, Suite C-5
    City
    Costa Mesa
    State
    CA
    ZIP
    92627
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220901

    Owner / Operator

    Firm Name
    Subchondral Solutions
    Operator Number
    10062793
    Address
    1725 Monrovia Ave
    City
    Costa Mesa
    State
    CA
    Postal Code
    92627
    Country
    US
    Correspondent
    James Barley

    Products

    Device Name Product Code
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Screw, Fixation, Bone HWC
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    SCS UE Implant and Delivery System S-Core HA Coated Implant SS Sports Implant and Delivery System S-Core Delivery Instruments

    Establishment Types

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