BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AMEND SURGICAL, INC.

    Reg #: 3012161787 · FEI: 3012161787 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    AMEND SURGICAL, INC.
    Registration Number
    3012161787
    FEI Number
    3012161787
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    14000 NW 126th Ter
    City
    Alachua
    State
    FL
    ZIP
    32615
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161996

    Owner / Operator

    Firm Name
    Amend Surgical, Inc.
    Operator Number
    10051002
    Address
    14000 NW 126th Ter
    City
    Alachua
    State
    FL
    Postal Code
    32615
    Country
    US
    Correspondent
    Robby Lane

    Products

    Device Name Product Code
    Filler, Bone Void, Calcium Compound MQV
    Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MBP

    Proprietary Names

    APEX BG+ BioV Bioactive Glass with DBM Putty

    Establishment Types

    Manufacture Medical Device