BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BED BOARD

    K Number: K780230 · Decision Feb 28, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    0
    Applicant Total
    441
    Review Days
    19

    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
    BED BOARD
    K Number
    K780230
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6070
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Biomet, Inc.
    Date Received
    February 9, 1978
    Decision Date
    February 28, 1978
    Product Code
    FPS
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FPS Board, Bed

    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. →