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

    MIMIX MP BONE VOID FILLER

    K Number: K043280 · Decision Dec 21, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    43
    Applicant Total
    441
    Review Days
    25

    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
    MIMIX MP BONE VOID FILLER
    K Number
    K043280
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5300
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet, Inc.
    Date Received
    November 26, 2004
    Decision Date
    December 21, 2004
    Product Code
    GXP
    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
    GXP Methyl Methacrylate For Cranioplasty

    Similar 510(k) Clearances

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

    Permatage XT Settable Bone Putty

    FDA 510(k)
    FDA Class 2 ·Neurology

    Permatage Flowable, Settable Bone Paste

    FDA 510(k)
    FDA Class 2 ·Neurology

    MONTAGE XT Cranial Cement

    FDA 510(k)
    FDA Class 2 ·Neurology

    Permatage Settable Bone Putty

    FDA 510(k)
    FDA Class 2 ·Neurology

    Montage Flowable Settable, Resorbable Bone Paste

    FDA 510(k)
    FDA Class 2 ·Neurology

    MONTAGE-QS Settable, Resorbable Bone Putty

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

    Other Clearances by Biomet, Inc.

    K Number Device Name
    K251270 Taperloc® Complete Hip Stem
    K241014 Biomet Kirschner Wires (K-Wires)
    K222760 StageOne™ Select Hip Cement Spacer Molds
    K221968 StageOne™ Shoulder Cement Spacer Molds
    K213287 StageOne Knee Cement Spacer Molds
    K212431 Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve
    K212435 Comprehensive Humeral Fracture Positioning Sleeves
    K210192 A.L.P.S. Clavicle Plating System
    K193214 WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws
    K193546 Distal Centralizers
    Search all 441 clearances from Biomet, Inc. →