BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MECRON(R) ACETABULAR NETS TM

    K Number: K820619 · Decision May 14, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    162
    Applicant Total
    6
    Review Days
    67

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MECRON(R) ACETABULAR NETS TM
    K Number
    K820619
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Serrano Intl.
    Date Received
    March 8, 1982
    Decision Date
    May 14, 1982
    Product Code
    FTM
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FTM Mesh, Surgical

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FTM), ordered by most recent decision date.

    Endoform Reconstructive Template - PLGA

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OviTex PRS (Long-Term Resorbable)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CanGaroo RM Antibacterial Envelope

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OviTex PRS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Peri-Guard and Supple Peri-Guard

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OviTex PRS (Long Term Resorbable)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Serrano Intl.

    K Number Device Name
    K851409 UNILOC TOTAL HIP PROSTHESIS
    K820899 MECRON VOORHOEVE TITANIUM SHEATH
    K820852 MECRON CONCAVEX FLEXIBLE INTRAMEDULLARY
    K810497 BONE FIXACTION SCREW
    K810205 MECRON CANCELLOUS CANNULATED BONE SCREWS