BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NOVABONE PRODUCTS, LLC

    Reg #: 3003768919 · FEI: 3003768919 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    33
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    NOVABONE PRODUCTS, LLC
    Registration Number
    3003768919
    FEI Number
    3003768919
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    13510 NW US Highway 441
    City
    ALACHUA
    State
    FL
    ZIP
    32615
    Country
    US

    Regulatory Submissions

    510(k) Number
    K100671

    Owner / Operator

    Firm Name
    NOVABONE PRODUCTS, LLC
    Operator Number
    9052139
    Address
    13510 NW US Highway 441
    City
    Alachua
    State
    FL
    Postal Code
    32615
    Country
    US

    Products

    Device Name Product Code
    Bone Grafting Material, Synthetic LYC
    Syringe, Restorative And Impression Material EID
    Wound Dressing With Animal-Derived Material(S) KGN
    Filler, Bone Void, Calcium Compound MQV

    Proprietary Names

    Cartridge Dispenser PerioGlas Bioactive Synthetic Bone Graft Putty Cartridges Bioactive Synthetic Bone Graft Dental Putty Cartridges NovaBone Cartridge Applicator Gun Cartridge Applicator Gun NovaForm Resorbable Collagen Bioglass Dressing Wound Matrix NovaShield PerioGlas Bioactive Synthetic Bone Graft Particulate Bioactive Strip Oxford: Bioactive Matrix Strip SurMatrix Synthetic Bio Active Strip Resorbable Bioglass Bone Graft Substitute Bioactive Synthetic Bone Graft NovaBone putty trocar cannula Bioactive Synthetic Bone Graft Dental Morsels Porous Granules Bioactive Synthetic Bone Graft MIS Cartridge Delivery System MacroFORM Bioactive MIS Composite SurMatrix Synthetic Moldable Composite MacroFORM Bioactive Moldable Composite Bioactive Synthetic Bone Graft Porous Morsels BTB - BioActive Bone Graft Putty Bioactive Synthetic Bone Graft Putty Oxford: Bioactive Matrix Bio Putty SurMatrix Synthetic Putty Bioactive Synthetic Bone Graft IRM Bioactive Synthetic Bone Graft MacroPor IRM Oxford: Bioactive Matrix IRM Putty SurMatrix Synthetic Bone Wax Bioactive Synthetic Bone Graft MacroPor-Si+ SurMatrix Synthetic Putty Plus NovaPlug Resorbable Collagen Plug NovaTape Resorbable Collagen Tape

    Establishment Types

    Manufacture Medical Device