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

    OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE

    K Number: K121818 · Decision Feb 7, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    55
    Applicant Total
    3
    Review Days
    232

    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
    OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE
    K Number
    K121818
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Oxford Performance Materials
    Date Received
    June 20, 2012
    Decision Date
    February 7, 2013
    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 Oxford Performance Materials

    K Number Device Name
    K142005 SpineFab Vertebral Body Replacement (VBR) System
    K133809 OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE