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

    STRYKER CUSTOM TI IMPLANT

    K Number: K052871 · Decision Dec 16, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    55
    Applicant Total
    12
    Review Days
    66

    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
    STRYKER CUSTOM TI IMPLANT
    K Number
    K052871
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Leibinger
    Date Received
    October 11, 2005
    Decision Date
    December 16, 2005
    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 Stryker Leibinger

    K Number Device Name
    K043250 STRYKER PATIENT SPECIFIC POLYMER IMPLANT
    K041651 STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM
    K040022 STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM
    K022579 STRYKER NAVIGATION SYSTEM-KNEE MODULE
    K023449 NON-INVASIVE PATIENT FIXATION SYSTEM
    K013775 TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM
    K012380 MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY
    K000594 LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE
    K000349 MOTORIZED MICRO MULTILEAF COLLIMATOR
    K000348 COLORADO MICRODISSECTION NEEDLE
    Search all 12 clearances from Stryker Leibinger →