BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Tyber6592 (WH,CH1) - Tyber Medical ACIF; Tyber Medical ALIF; Tyber Medical DLIF; Tyber Medical OLIF; Tyber Medical PLIF;

    Reg #: 2245304 · FEI: 2245304 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ISOMEDIX OPERATIONS INC.
    Registration Number
    2245304
    FEI Number
    2245304
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9 Apollo Dr
    City
    WHIPPANY
    State
    NJ
    ZIP
    07981
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130573

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    1527821
    Address
    5960 Heisley Rd, --
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Bone Graft, Cervical ODP

    Proprietary Names

    Tyber6592 (WH,CH1) - Tyber Medical ACIF; Tyber Medical ALIF; Tyber Medical DLIF; Tyber Medical OLIF; Tyber Medical PLIF; Tyber6592 (WH,CH1) - Tyber Medical TLIF

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)