BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ETEX Corporation

    Reg #: 1225112 · FEI: 3000206397 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    21
    Establishment Types
    3
    Classifications
    7

    Registration Details

    Registration Name
    ETEX Corporation
    Registration Number
    1225112
    FEI Number
    3000206397
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    55 Messina Dr
    City
    Braintree
    State
    MA
    ZIP
    02184
    Country
    US

    Regulatory Submissions

    510(k) Number
    K080329

    Owner / Operator

    Firm Name
    Zimmer Biomet ETEX
    Operator Number
    9014709
    Address
    55 Messina Dr., --
    City
    Braintree
    State
    MA
    Postal Code
    02184
    Country
    US
    Correspondent
    Stephanie Lynch

    Products

    Device Name Product Code
    Filler, Bone Void, Calcium Compound MQV
    Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MBP
    Syringe, Piston FMF
    Bone Grafting Material, Human Source NUN
    Bone Grafting Material, Synthetic LYC
    Instrument, Manual, Surgical, General Use MDM
    Filler, Bone Void, Calcium Compound, Lower Extremity Use, Use On Bone Marrow Lesions QCG

    Proprietary Names

    EquivaBone N-Force Blue Mixing and Delivery System Precision Mixing and Delivery System Etex Mixing and Delivery System Beta BSM Gamma BSM moldable EquivaBone Osteoinductive Bone Graft Substitute Alpha BSM Gamma-BSM EquivaBone Bone Grafting Material Beta-BSM AccuFill; AccuFill PreFill CarriGen PF AccuFill PF Beta BSM ™; Flow-FX 2; OssiFuse Bone Substitute Material N-Force Blue CarriGen Flow-FX 2 AccuFill Precision Cannula AccuFill; CarriGen; N-Force Blue

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Device in the United States for Export Only