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

    Longeviti ClearFit Cranial Implant

    K Number: K203349 · Decision Dec 16, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    55
    Applicant Total
    8
    Review Days
    33

    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
    Longeviti ClearFit Cranial Implant
    K Number
    K203349
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Longeviti Neuro Solutions, LLC
    Date Received
    November 13, 2020
    Decision Date
    December 16, 2020
    Product Code
    GXN
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GXN Plate, Cranioplasty, Preformed, Non-Alterable

    Similar 510(k) Clearances

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

    3D MAC Titanium Cranial Plate (TCP) System

    FDA 510(k)
    FDA Class 2 ·Neurology

    EASYMADE-TI

    FDA 510(k)
    FDA Class 2 ·Neurology

    METICULY Patient-specific titanium mesh implant

    FDA 510(k)
    FDA Class 2 ·Neurology

    Synthes Patient Specific Implants

    FDA 510(k)
    FDA Class 2 ·Neurology

    KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

    FDA 510(k)
    FDA Class 2 ·Neurology

    CustomizedBone Service

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Longeviti Neuro Solutions, LLC

    K Number Device Name
    K231920 Longeviti ClearFit OTS Cranial Implant
    K212058 Longeviti ClearFit™ OTS Cranial Implants
    K211514 Longeviti PorousFit implant
    K210616 Longeviti PMMA Static Cranial Implant
    K202901 Longeviti ClearFit Cranial Implant
    K191210 Longeviti ClearFit Cranial Implant
    K170410 Longeviti PMMA Static Cranial Implant