BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AlloFuse Plus Paste, AlloFuse Plus Putty

    Reg #: 3012448339 · FEI: 3012448339 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    STERI-TEK
    Registration Number
    3012448339
    FEI Number
    3012448339
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    48225 Lakeview Blvd
    City
    Fremont
    State
    CA
    ZIP
    94538
    Country
    US

    Regulatory Submissions

    510(k) Number
    K103036

    Owner / Operator

    Firm Name
    Steri-Tek
    Operator Number
    10051493
    Address
    48225 Lakeview Blvd.
    City
    Fremont
    State
    CA
    Postal Code
    94538
    Country
    US
    Correspondent
    Larry Nichols Nichols

    Products

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

    Proprietary Names

    AlloFuse Plus Paste, AlloFuse Plus Putty

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)