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

    THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX

    K Number: K040756 · Decision Jul 14, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    162
    Applicant Total
    65
    Review Days
    112

    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
    THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX
    K Number
    K040756
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Implex Corp.
    Date Received
    March 24, 2004
    Decision Date
    July 14, 2004
    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 Implex Corp.

    K Number Device Name
    K051978 TRABECULAR METAL VERTEBRAL BODY REPLACEMENT
    K051196 TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1
    K040487 TRABECULAR METAL KNEE SYSTEM AUGMENTS
    K040630 TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ
    K031962 NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS
    K033384 THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ
    K032527 HEDROCEL VERTEBRAL BODY REPLACEMENT
    K032344 THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330
    K031449 MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION
    K032282 MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM
    Search all 65 clearances from Implex Corp. →