BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Cerafix® Dura Substitute

    Reg #: 3012429393 · FEI: 3012429393 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Acera Surgical, Inc. C/O Linda Braddon, PhD
    Registration Number
    3012429393
    FEI Number
    3012429393
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7842 Hickory Flat Hwy Ste B
    City
    Woodstock
    State
    GA
    ZIP
    30188
    Country
    US

    Regulatory Submissions

    510(k) Number
    K153613

    Owner / Operator

    Firm Name
    Acera Surgical, Inc.
    Operator Number
    10051479
    Address
    1650 Des Peres Rd, Ste 120
    City
    Saint Louis
    State
    MO
    Postal Code
    63131
    Country
    US
    Correspondent
    Lily Jeng

    Products

    Device Name Product Code
    Dura Substitute GXQ

    Proprietary Names

    Cerafix® Dura Substitute

    Establishment Types

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