BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ALAFAIR BIOSCIENCES, INC.

    Reg #: 3012669262 · FEI: 3012669262 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    ALAFAIR BIOSCIENCES, INC.
    Registration Number
    3012669262
    FEI Number
    3012669262
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6101 W. Courtyard Dr., Ste 1-225
    City
    Austin
    State
    TX
    ZIP
    78730
    Country
    US

    Regulatory Submissions

    510(k) Number
    K251505

    Owner / Operator

    Firm Name
    Alafair Biosciences, Inc.
    Operator Number
    10052283
    Address
    6101 West Courtyard Drive, Suite #1-225
    City
    Austin
    State
    TX
    Postal Code
    78730
    Country
    US
    Correspondent
    Sarah Mayes

    Products

    Device Name Product Code
    Cuff, Nerve JXI
    Mesh, Surgical FTM
    Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon OWW

    Proprietary Names

    VersaCoat Nerve Protector VersaCoat Tendon Protector VersaWrap Nerve Protector VersaWrap Tendon Protector VersaWrap

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device